# K012644: Reprocessed Trocars and Cannulas

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instruments Service and Savings, Inc.
- Decided: Jul 29, 2002 after 350 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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 no predicate by number.

## Recalls of this device
- May 3, 2013 · Class II · Z-1643-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

## Indications for use
Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.

Source page: https://510kreport.com/device/K012644
Methodology: https://510kreport.com/methodology