510(k) · Cleared

Cleared

Deroyal Industries Disposable Surgical Trocar/Cannula

K974763510(k) TraditionalCleared Jul 10, 1998203-day reviewClass II21 CFR 884.1720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Deroyal Industries, Inc. · HET Laparoscope, Gynecologic (And Accessories)

Cleared on Jul 10, 1998 as substantially equivalent to K862611 (United States Surgical, A Division of Tyco Healthc, 1986) and 6 other predicates after a 203-day review. Its family tree reaches back 1 generation to 1986.

Decided: Jul 10, 1998
Review: 203 days
Class: Class II
Product code: HET
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K862611 (1986). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK862611 Sterile Disposable Trocar-Sleeve DevicesUnited States Surgical, A Division of Tyco Healthc · 1986
This deviceK974763 Deroyal Industries Disposable Surgical Trocar/CannulaDeroyal Industries, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K862611	Sterile Disposable Trocar-Sleeve Devices	United States Surgical, A Division of Tyco Healthc	1986	—
0 (this device)	K974763	Deroyal Industries Disposable Surgical Trocar/Cannula	Deroyal Industries, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1990	2	0
1991	1	0
1993	2	0

FIG. 1 — Lineage of K974763, 1986–1998Source: 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 HET? 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 HET device

#1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (7)

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
*	K862611	Sterile Disposable Trocar-Sleeve Devices Summary page 1 …unt tip Trocar/Cannula Classified Name: Endoscope and accessories, § 876.1500, Class Il (3) Predicates: Auto Suture® Surgiport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4)…	United States Surgical, A Division of Tyco Healthc	1986	—
*	K874879	Auto Suture (R) Surgiport Dispos Surg Trocar/Sleeve Summary page 1 …rocar/Cannula Classified Name: Endoscope and accessories, § 876.1500, Class Il (3) Predicates: Auto Suture® Surgiport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4) Descripti…	United States Surgical, A Division of Tyco Healthc	1987	—
*	K900487	Modified Auto Suture Surgiport Trocar & Sleeve Summary page 1 …nula Classified Name: Endoscope and accessories, § 876.1500, Class Il (3) Predicates: Auto Suture® Surgiport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4) Description of Dev…	United States Surgical, A Division of Tyco Healthc	1990	—
*	K903419	Modified Surgiport Disposable Trocar and Sleeve Summary page 1 …ssified Name: Endoscope and accessories, § 876.1500, Class Il (3) Predicates: Auto Suture® Surgiport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4) Description of Device: The…	United States Surgical, A Division of Tyco Healthc	1990	—
*	K912398	Endopath Surg Disp Trocar (Shield/Unshielded),Modif Summary page 1 …Auto Suture® Surgiport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4) Description of Device: The DeRoyal Disposable Surgical Trocar/Cannula is a disposable single patient use…	ETHICON, Inc.	1991	—
*	K924035	Endopath II Disposable Surgical Trocar & Sleeve Summary page 1 …ure® Surgiport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4) Description of Device: The DeRoyal Disposable Surgical Trocar/Cannula is a disposable single patient use device f…	Ethicon Endo-Surgery, Inc.	1993	—
*	K932282	Endopath II Disposable Surgical Trocar & Sleeve Summary page 1 …iport® Disposable Trocar & Sleeve (510(k) nos. K862611, K874879, K900487, K903419) Ethicon Endopath Disposable Surgical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) (4) Description of Device: The DeRoyal Disposable Surgical Trocar/Cannula is a disposable single patient use device fabricated…	Ethicon Endo-Surgery, Inc.	1993	—

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 7 ancestors has a recall.

How does its category compare?

All HET devices

HET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HET

2in 2025

2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2007high 269 (2021) · low 176 (2008)2026

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

Recalls per year · HET

4in 2023

2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HET

4,513in 2025

2007high 4,513 (2025) · low 44 (2019)2025

MAUDE reports naming product code HET, 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	0	—	0	181
2008	3	176	4	359
2009	1	—	1	403
2010	1	—	0	214
2011	2	—	0	417
2012	2	—	0	1,118
2013	2	—	0	1,035
2014	0	—	0	175
2015	2	—	1	124
2016	0	—	0	205
2017	2	—	0	89
2018	1	—	0	53
2019	2	—	0	44
2020	2	—	0	49
2021	4	269	0	132
2022	1	—	1	216
2023	0	—	4	824
2024	0	—	0	3,496
2025	2	—	0	4,513
2026	0	—	0	—

What is it indicated for?

The DeRoyal Industries Disposable Surgical Trocar/Cannula is a single patient use disposable device intended for use during operative and/or diagnostic surgery to puncture/penetrate the abdominal wall and to serve as a port of entry for laparoscopic instruments (i.e. laparoscope, forceps, scissors, aspiration/irrigation cannula, etc.).

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/K974763 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974763: Deroyal Industries Disposable Surgical Trocar/Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974763

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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