# K974763: Deroyal Industries Disposable Surgical Trocar/Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Jul 10, 1998 after 203 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862611 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862611: Sterile Disposable Trocar-Sleeve Devices, United States Surgical, A Division of Tyco Healthc (1986) Summary page 1.
- K874879: Auto Suture (R) Surgiport Dispos Surg Trocar/Sleeve, United States Surgical, A Division of Tyco Healthc (1987) Summary page 1.
- K900487: Modified Auto Suture Surgiport Trocar & Sleeve, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K903419: Modified Surgiport Disposable Trocar and Sleeve, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K912398: Endopath Surg Disp Trocar (Shield/Unshielded),Modif, ETHICON, Inc. (1991) Summary page 1.
- K924035: Endopath II Disposable Surgical Trocar & Sleeve, Ethicon Endo-Surgery, Inc. (1993) Summary page 1.
- K932282: Endopath II Disposable Surgical Trocar & Sleeve, Ethicon Endo-Surgery, Inc. (1993) Summary page 1.

## Indications for use
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.).

Source page: https://510kreport.com/device/K974763
Methodology: https://510kreport.com/methodology