# K150549: Reactor (TM) Trocar and Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Sharp Medical Prducts, LLC
- Decided: Jun 1, 2015 after 90 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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
Longest line of descent: 1 generation back to K935086 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935086: Auto Suture Disposable Optical Trocar, United States Surgical, A Division of Tyco Healthc (1994) Summary page 4.

## Most influential descendants
- K252714: C-Lant Port (2026), 0 descendants of its own

## Recalls of this device
- Feb 8, 2021 · Class II · Z-1366-2021: Non-conformity (holes/punctures or deep creases) in the sterile barrier.

## Indications for use
The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port of entry into the thoracic cavity and allows the user to create and maintain limited access into the chest for the intention of chest tube placement.

Source page: https://510kreport.com/device/K150549
Methodology: https://510kreport.com/methodology