510(k) Report

510(k) · Cleared

Cleared

Autosuture Modified Versaport Trocar with Fixation Sleeve

K062326510(k) SpecialCleared Sep 1, 200623-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 Sep 1, 2006 after a 23-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.

Decided
Sep 1, 2006
Review
23 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

16 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2016: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2023: 3 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared2024: 2 descendants cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK062326 Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006
  2. Descendant · cites it directly · 7 of its ownK151548 VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015
  3. Descendant · cites it directly · 5 of its ownK190029 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019
  4. Descendant · 2 generations on · 1 of its ownK222695 troCarWash™ SystemBiotex, Inc. · 2023
  5. Descendant · 2 generations on · 1 of its ownK163654 VersaOne fascial closure system bladed trocar, VersaOne fascial…Covidien, LLC · 2017
  6. Descendant · 2 generations on · 1 of its ownK162584 VersaOne Bladeless TrocarCovidien · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2015: 12016: 32017: 22019: 12020: 12023: 32024: 22025: 12026: 2
2015high 3 (2016) · low 0 (2018)2026

Most influential descendants

Showing 5 of 16 · See all
  • K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien · 2015 · cites it directly7descendants
  • K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019 · cites it directly5descendants
  • K222695troCarWash™ SystemBiotex, Inc. · 2023 · 2 generations on1descendant
  • K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless…Covidien, LLC · 2017 · 2 generations on1descendant
  • K162584VersaOne Bladeless TrocarCovidien · 2016 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc2006—
+1K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien2015—
+1K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd2019—
+2K222695troCarWash™ SystemBiotex, Inc.2023—
+2K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system…Covidien, LLC2017—
+2K162584VersaOne Bladeless TrocarCovidien2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201630
201720
201910
202010
202330
202420
202510
202620
FIG. 1 — Lineage of K062326, 2006–2026Source: 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), 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 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? (2)

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
*—autosuture™ VERSAPORT trocar
Named without a submission number
—
*—Ethicon Endopath™ III Dilating tip Trocar
Named without a submission number
—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarCovidien20157
K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd20195
K152149VersaOne Bladed Trocar 5mmCovidien20161
K172093Reprocessed Covidien TrocarRenovo, Inc.20170

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, K151548 (Covidien, 2015) has gone furthest, with 7 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—

What is it indicated for?

The autosutureTM Modified VERSAPORT TM trocar with fixation sleeve is intended

for use in a variety of gynecologic, general, thoracic and urologic endoscopic

procedures to create and maintain a port of entry.

Indications for use as stated in the FDA summary.

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
  • K061095Auto Sutur Endo Gia StaplersUnited 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/K062326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062326: Autosuture Modified Versaport Trocar with Fixation Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062326

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026