510(k) Report

510(k) · Cleared

Cleared

Auto Suture (R) Articulating Endoscopic Scissors

K914752510(k) TraditionalCleared Jun 11, 1992233-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

United States Surgical, A Division of Tyco Healthc · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 11, 1992 after a 233-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.

Decided
Jun 11, 1992
Review
233 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

53 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2014: 4 descendants cleared2021: 6 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2012: 1 descendant cleared2017: 2 descendants cleared2016: 1 descendant cleared2023: 7 descendants cleared2018: 3 descendants cleared2015: 1 descendant cleared2024: 7 descendants cleared2019: 2 descendants cleared2026: 3 descendants cleared2025: 8 descendants cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK914752 Auto Suture (R) Articulating Endoscopic ScissorsUnited States Surgical, A Division of Tyco Healthc · 1992
  2. Descendant · cites it directly · 52 of its ownK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
  3. Descendant · 2 generations on · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
  4. Descendant · 3 generations on · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
  5. Descendant · 4 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
  6. Descendant · 5 generations on · 20 of its ownK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12013: 22014: 42015: 12016: 12017: 22018: 32019: 22020: 42021: 62022: 12023: 72024: 72025: 82026: 3
2009high 8 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 53 · See all
  • K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009 · cites it directly52descendants
  • K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · 2 generations on39descendants
  • K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · 3 generations on22descendants
  • K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 4 generations on21descendants
  • K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · 5 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914752Auto Suture (R) Articulating Endoscopic ScissorsUnited States Surgical, A Division of Tyco Healthc1992—
+1K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States2009—
+2K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.20136
+3K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2014—
+4K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20189
+5K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.20194

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201320
201440
201510
201610
201720
201830
201920
202040
202160
202210
202370
202470
202580
202630
FIG. 1 — Lineage of K914752, 1992–2026Source: 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.

Planning a device in GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 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? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States200952
K140662Flex Endoscopic InstrumentsDesign Standards Corp.20140

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?

  • Of its descendants, K091869 (Covidien Lp, Formerly Registered AS United States, 2009) has gone furthest, with 52 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in GCJ

The GCJ category page

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https://510kreport.com/device/K914752 · printed Nov 4, 2026

Cite this page

510(k) Report. “K914752: Auto Suture (R) Articulating Endoscopic Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914752

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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