510(k) Report

510(k) · Cleared

Cleared

da Vinci Xi Surgical System

K153276510(k) TraditionalCleared Aug 7, 2016269-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument

Cleared on Aug 7, 2016 as substantially equivalent to K131861 (Intuitive Surgical, Inc., 2014) and 4 other predicates after a 269-day review. Its family tree reaches back 15 generations to 1994. 23 later devices descend from it.

Decided
Aug 7, 2016
Review
269 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
5

Its longest line of descent runs back 15 generations to K930667 (1994). 56 ancestors in all, the oldest K811390 (1981). 23 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2005: 2 other ancestors2004: 4 other ancestors2002: 3 other ancestors2001: 5 other ancestors2003: 1 other ancestor1999: 3 other ancestors1997: 7 other ancestors1993: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1991: 3 other ancestors1988: 1 other ancestor1981: 1 other ancestor2017: 2 descendants cleared2025: 5 descendants cleared2018: 4 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2024: 3 descendants cleared2026: 5 descendants clearedK930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK123463 · Intuitive Surgical DA Vinci SI Surgical System Smartpedals · Intuitive Surgical, Inc. · 2012 · recalledK131861 · DA Vinci Surgical System, Endowrist Instruments and Accessories · Intuitive Surgical, Inc. · 2014 · recalledK152578 · da Vinci Surgical System, Model IS4000 · Intuitive Surgical, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 12 other ancestors3 generations back: 8 other ancestors4 generations back: 13 other ancestors5 generations back: 5 other ancestors6 generations back: 3 other ancestors 1 generation forward: 12 descendants2 generations forward: 7 descendants3 generations forward: 4 descendants K152578 · da Vinci Surgical System, Model IS4000 · Intuitive Surgical, Inc. · 2016K131861 · DA Vinci Surgical System, Endowrist Instruments and Accessories · Intuitive Surgical, Inc. · 2014 · recalledK123463 · Intuitive Surgical DA Vinci SI Surgical System Smartpedals · Intuitive Surgical, Inc. · 2012 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−15−10−50
  1. Root · 15 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 11 generations between
  3. 3 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  4. 2 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  5. 1 generation backK152578 da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. · 2016
  6. This deviceK153276 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2016
  7. Descendant · cites it directly · 22 of its ownK170713 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
  8. Descendant · cites it directly · 20 of its ownK171632 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
  9. Descendant · cites it directly · 18 of its ownK173585 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
  10. Descendant · cites it directly · 18 of its ownK173842 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
  11. Descendant · cites it directly · 18 of its ownK172643 da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
Show all 15 generations
  1. Root · 15 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 14 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 13 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 12 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 11 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 10 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 9 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 8 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 7 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 6 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 5 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 4 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  13. 3 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  14. 2 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  15. 1 generation backK152578 da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. · 2016
  16. This deviceK153276 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2016

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2017: 22018: 42020: 22021: 12022: 12024: 32025: 52026: 5
2017high 5 (2025) · low 0 (2019)2026

Most influential descendants

Showing 5 of 23 · See all
  • K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017 · cites it directly22descendants
  • K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017 · cites it directly20descendants
  • K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018 · cites it directly18descendants
  • K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018 · cites it directly18descendants
  • K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018 · cites it directly18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−14K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−13K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−12K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−11K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−10K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−9K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−8K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−7K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−6K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−5K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−4K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
−3K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
−2K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201480
−1K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.2016—
0 (this device)K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.2016—
+1K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.2017—
+1K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.2017—
+1K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.2018—
+1K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.2018—
+1K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199130
199210
199320
199420
199520
199770
199820
199930
200150
200230
200310
200440
200520
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201840
202020
202110
202210
202430
202550
202650
FIG. 1 — Lineage of K153276, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NAY device

  1. #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K131861DA Vinci Surgical System, Endowrist Instruments and Accessories
Summary page 4
…Submission Type: Traditional 510(k) III. PREDICATE DEVICE INFORMATION: Predicate Device: Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081…
Intuitive Surgical, Inc.201480
*K152578da Vinci Surgical System, Model IS4000
Cleared while this submission was under review
Summary page 4
…al 510(k) III. PREDICATE DEVICE INFORMATION: Predicate Device: Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123…
Intuitive Surgical, Inc.2016—
*K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000
Summary page 4
…Vinci Surgical System, Model IS4000 (K131861, K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993) IV. DEVICE DESCRIPTION: This 510(k) is for a labeling modification only, to inclu…
Intuitive Surgical, Inc.200925
*K123463Intuitive Surgical DA Vinci SI Surgical System Smartpedals
Summary page 4
…K131861, K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993) IV. DEVICE DESCRIPTION: This 510(k) is for a labeling modification only, to include the following additional represent…
Intuitive Surgical, Inc.20122
*K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000
Summary page 4
…K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993) IV. DEVICE DESCRIPTION: This 510(k) is for a labeling modification only, to include the following additional representative, sp…
Intuitive Surgical, Inc.20093

Also cleared against K131861: 31 other devices →

What descends from it? (23)

See all 23

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722
K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720
K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818
K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818
K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818
K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817
K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016
K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015
K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114
K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 14 of the 56 ancestors have a recall of any class.
  • Of its descendants, K170713 (Intuitive Surgical, Inc., 2017) has gone furthest, with 22 descendants of its own.
  • 31 other devices also cite its predicate K131861.

How does its category compare?

All NAY devices

NAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · NAY

16in 2025

2008: 42009: 32010: 12011: 72012: 42013: 42014: 92015: 32016: 82017: 162018: 152019: 82020: 92021: 112022: 62023: 52024: 102025: 162026 (partial year): 7
2007high 16 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAY

117in 2025

2008: 189 days median2009: 253 days median2011: 191 days median2012: 106 days median2013: 144 days median2014: 143 days median2015: 99 days median2016: 197 days median2017: 107 days median2018: 152 days median2019: 73 days median2020: 212 days median2021: 61 days median2022: 57 days median2023: 141 days median2024: 126 days median2025: 117 days median2026 (partial year): 89 days median
2007high 253 (2009) · low 57 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NAY

1in 2025

2007: 112008: 32009: 12011: 22012: 12013: 62014: 252015: 32016: 12017: 12018: 22019: 52021: 32022: 32023: 2, 1 Class I2024: 402025: 12026 (partial year): 4, 1 Class I
2007high 40 (2024) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NAY

48,456in 2025

2007: 1332008: 2242009: 3802010: 6232011: 5012012: 1,5522013: 6,2172014: 6,1352015: 1,7222016: 1,0772017: 1,0492018: 1,0742019: 1,1542020: 1,5582021: 1,9972022: 5,7272023: 10,8982024: 12,8722025: 48,456
2007high 48,456 (2025) · low 133 (2007)2025

MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11133
200841893224
200932531380
20101—0623
201171912501
2012410611,552
2013414466,217
20149143256,135
201539931,722
2016819711,077
20171610711,049
20181515221,074
201987351,154
2020921201,558
2021116131,997
202265735,727
202351412 (1)10,898
2024101264012,872
202516117148,456
20267894 (1)—

What is it indicated for?

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp…

Read the full statement (147 words)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Indications for use as stated in the FDA summary.

Also cleared against K131861

31 other devices cite the same predicate.

  • K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent…Restore Robotics · 2026
  • K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. · 2025
  • K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical · 2024
  • K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc. · 20246 recalls
  • K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. · 2023
  • K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. · 2022

More from Intuitive Surgical, Inc.

181 FDA decisions under this applicant name. See the company

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026

Recent decisions in NAY

The NAY category page

  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026

https://510kreport.com/device/K153276 · printed Nov 3, 2026

Cite this page

510(k) Report. “K153276: da Vinci Xi Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153276

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026