# K960936: Resposable Trocar System [5MM, 5MM Short, 10MM and 12MM Sizes]

- Pathway: 510(k) (Traditional)
- Applicant: Origin Medsystems, Inc.
- Decided: Jul 24, 1996 after 138 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ORIGIN Sensing Tip Trocar (OMS-TSS, OMS-T10S, OMST1112S): named in the summary without a submission number

## Indications for use
The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

Source page: https://510kreport.com/device/K960936
Methodology: https://510kreport.com/methodology