# K092684: Laparoscopic Retractors

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Jan 22, 2010 after 143 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933008 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933008: Retractors and Scraper, Baxter Healthcare Corp (1994) Summary page 1.
- K930667: Reusable Laparoscopic Instruments, Snowden-Pencer (1994) Summary page 1.

## Most influential descendants
- K112659: Surgical Retractors (2012), 0 descendants of its own
- K100442: Fastclamp Endoscopic Clamping System (2010), 0 descendants of its own

## Recalls of this device
- Jul 1, 2016 · Class I · Z-2212-2016: BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were 

## Indications for use
Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.

Source page: https://510kreport.com/device/K092684
Methodology: https://510kreport.com/methodology