# K112659: Surgical Retractors

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Innovations Plc
- Decided: Mar 9, 2012 after 178 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933008 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092684: Laparoscopic Retractors, Cardinal Health, Inc. (2010) Summary page 1.
- K942002: Retractor, Automated Medical Products Corp. (1994) Summary page 2.
- K914190: Auto Suture (R) Endoscopic Fan Retractor, United States Surgical, A Division of Tyco Healthc (1992) Summary page 2.

## Indications for use
This device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate or retract organs and tissues to provide better access as well as visualization and stabilization of surgical sites.

Source page: https://510kreport.com/device/K112659
Methodology: https://510kreport.com/methodology