510(k) · Cleared

Cleared

Trocar Cannula

K963115510(k) TraditionalCleared Feb 12, 1997184-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 Feb 12, 1997 as substantially equivalent to K954108 (United States Surgical, A Division of Tyco Healthc, 1995) after a 184-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.

Decided: Feb 12, 1997
Review: 184 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954108 (1995). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954108 Modified VersaportUnited States Surgical, A Division of Tyco Healthc · 1995
This deviceK963115 Trocar CannulaUnited States Surgical, A Division of Tyco Healthc · 1997
Descendant · cites it directly · 3 of its ownK043594 Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar…Vanguard Medical Concepts, Inc. · 2005 · Recalled
Descendant · 2 generations on · 2 of its ownK062497 Reprocessed TrocarsAscent Healthcare Solutions · 2007 · Recalled
Descendant · 3 generations on · 0 of its ownK132629 Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013
Descendant · 3 generations on · 0 of its ownK100080 Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K043594Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesVanguard Medical Concepts, Inc. · 2005 · cites it directly3descendants
K062497Reprocessed TrocarsAscent Healthcare Solutions · 2007 · 2 generations on2descendants
K132629Reprocessed Dilating Tip TrocarsStryker Sustainability Solutions · 2013 · 3 generations on0descendants
K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 2010 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954108	Modified Versaport	United States Surgical, A Division of Tyco Healthc	1995	—
0 (this device)	K963115	Trocar Cannula	United States Surgical, A Division of Tyco Healthc	1997	—
+1	K043594	Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories	Vanguard Medical Concepts, Inc.	2005	1
+2	K062497	Reprocessed Trocars	Ascent Healthcare Solutions	2007	2
+3	K132629	Reprocessed Dilating Tip Trocars	Stryker Sustainability Solutions	2013	—
+3	K100080	Reprocessed Trocars, Model B5LT and CB5LT	Ascent Healthcare Solutions	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2010	1	0
2013	1	0

FIG. 1 — Lineage of K963115, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K954108	Modified Versaport Summary page 1 …l Instrument for general use COMMON NAME: Trocar Cannula PROPRIETARY NAME: Trademark name not yet determined. PREDICATE DEVICE: Auto Suture* Modified Versaport* Trocar (K954108) DEVICE DESCRIPTION: The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plas…	United States Surgical, A Division of Tyco Healthc	1995	—

Also cleared against K954108: 5 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043594	Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories	Vanguard Medical Concepts, Inc.	2005	3

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?

Its one ancestor has no recall.
Of its descendants, K043594 (Vanguard Medical Concepts, Inc., 2005) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K954108.

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

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

Both the Auto Suture* Cannula™* and the Auto Suture* Modified Versaport* Trocar (K954108) are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963115 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963115: Trocar Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963115

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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