# K022989: Radlite Tissue Retractor System

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Biosurgery
- Decided: Nov 25, 2002 after 77 days
- Product code: FSW (Light, Surgical, Endoscopic)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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 K930667 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960400: Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts), Snowden-Pencer (1996) Summary page 1.
- K973139: Endopath Ultra-Retractor/ Endopath Vessel Dissector, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.

## Indications for use
The RarUliteTM Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.

Source page: https://510kreport.com/device/K022989
Methodology: https://510kreport.com/methodology