510(k) Report

510(k) · Cleared

Cleared

Auto Suture Suture Closure

K954853510(k) TraditionalCleared Dec 20, 199558-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 Dec 20, 1995 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Dec 20, 1995
Review
58 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

19 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2023: 2 descendants cleared1998: 2 descendants cleared2021: 3 descendants cleared2010: 1 descendant cleared2004: 1 descendant cleared2013: 1 descendant cleared2007: 1 descendant cleared2015: 2 descendants cleared2024: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954853 Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc · 1995
  2. Descendant · cites it directly · 16 of its ownK981531 Suture Placement Device and AccessoriesLsi Solutions · 1998
  3. Descendant · 2 generations on · 6 of its ownK123811 StitchkitOrigami Surgical, LLC · 2013
  4. Descendant · 2 generations on · 6 of its ownK040232 Lsi Sew-Right R Series Suture Placement Device and Access Product…Lsi Solutions · 2004
  5. Descendant · 2 generations on · 5 of its ownK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
  6. Descendant · 3 generations on · 3 of its ownK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1998: 22004: 12007: 12010: 12013: 12014: 12015: 22016: 12018: 12019: 12020: 12021: 32023: 22024: 1
1998high 3 (2021) · low 0 (1999)2026

Most influential descendants

Showing 5 of 19 · See all
  • K981531Suture Placement Device and AccessoriesLsi Solutions · 1998 · cites it directly16descendants
  • K123811StitchkitOrigami Surgical, LLC · 2013 · 2 generations on6descendants
  • K040232Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model…Lsi Solutions · 2004 · 2 generations on6descendants
  • K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc. · 2010 · 2 generations on5descendants
  • K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954853Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc1995—
+1K981531Suture Placement Device and AccessoriesLsi Solutions1998—
+2K123811StitchkitOrigami Surgical, LLC2013—
+2K040232Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right…Lsi Solutions2004—
+2K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.2010—
+3K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200410
200710
201010
201310
201410
201520
201610
201810
201910
202010
202130
202320
202410
FIG. 1 — Lineage of K954853, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K981531Suture Placement Device and AccessoriesLsi Solutions199816
K231407StarFinPremium Medical Technology, LLC20230
K981631Influence Clip SystemInfluence, Inc.19980

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, K981531 (Lsi Solutions, 1998) has gone furthest, with 16 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

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K954853 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954853: Auto Suture Suture Closure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954853

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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