# K133345: Reveel Endoscopic Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Retraction Limited
- Decided: Apr 11, 2014 after 163 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: 1 generation back to K914190 (1992). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123110: Pretzelflex Surgical Retractor Model SHR7301, Surgical Innovations Plc (2013) Summary page 1.
- K914190: Auto Suture (R) Endoscopic Fan Retractor, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.
- K942002: Retractor, Automated Medical Products Corp. (1994) Summary page 1.

## Most influential descendants
- K162445: LiVac Retractor System (2016), 1 descendant of its own
- K243399: Boehringer Laboratories Liver Retractor (2025), 0 descendants of its own

## Indications for use
REVEEL is designed as an organ and tissue retractor for the use in endloscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites.

Source page: https://510kreport.com/device/K133345
Methodology: https://510kreport.com/methodology