510(k) Report

510(k) · Cleared

Cleared

Intuitive Surgical Ultrasonic Shears

K011281510(k) TraditionalCleared Jul 24, 200188-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 Jul 24, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 237 devices in its family, counting itself, has a Class I recall. 236 later devices descend from it.

Decided
Jul 24, 2001
Review
88 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
0

236 later devices descend from it, 4 citing it directly. 1 of the 237 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2009: 2 descendants cleared2005: 3 descendants cleared2014: 9 descendants cleared2011: 5 descendants cleared2010: 1 descendant cleared2008: 5 descendants cleared2013: 4 descendants cleared2006: 3 descendants cleared2017: 14 descendants cleared2012: 4 descendants cleared2019: 10 descendants cleared2018: 16 descendants cleared2016: 9 descendants cleared2020: 17 descendants cleared2021: 16 descendants cleared2022: 18 descendants cleared2015: 5 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2026: 22 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall1200020052010201520202025
  1. This deviceK011281 Intuitive Surgical Ultrasonic ShearsIntuitive Surgical, Inc. · 2001
  2. Descendant · cites it directly · 235 of its ownK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
  3. Descendant · cites it directly · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  4. Descendant · 2 generations on · 229 of its ownK043288 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  5. Descendant · 2 generations on · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  6. Descendant · 2 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled

Showing 5 of 236 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 32008: 52009: 22010: 12011: 52012: 42013: 42014: 92015: 52016: 92017: 142018: 162019: 102020: 172021: 162022: 182023: 192024: 222025: 312026: 22
2004high 31 (2025) · low 0 (2007)2026

Class I recalls in this family

  • K223095 Senhance Surgical System3 generations on · 2023

Most influential descendants

Showing 5 of 236 · See all
  • K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004 · cites it directly235descendants
  • K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly229descendants
  • K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 2 generations on229descendants
  • K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 2 generations on228descendants
  • K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · 2 generations on224descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011281Intuitive Surgical Ultrasonic ShearsIntuitive Surgical, Inc.2001—
+1K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc.2004—
+1K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
+2K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
+2K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
+2K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200630
200850
200920
201010
201150
201240
201340
201490
201550
201690
2017140
2018160
2019100
2020170
2021160
2022180
2023191
2024220
2025310
2026220
FIG. 1 — Lineage of K011281, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (236)

See all 236

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

NumberDeviceApplicantDecidedDescendants
K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc.2004235
K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229
K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.2009153
K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K042855 (Intuitive Surgical, Inc., 2004) has gone furthest, with 235 descendants of its own.

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.

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)—

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/K011281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011281: Intuitive Surgical Ultrasonic Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011281

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026