# K993544: Space-or Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Surgical Concepts (Asc)
- Decided: Dec 22, 1999 after 64 days
- Product code: FFO (Retractor, Self-Retaining)
- Device class: 1
- Regulation: 21 CFR 876.4730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lone Star Instruments Retractor System: named in the summary without a submission number
- (no number) Sklar Surgical Instruments ALM and Meyerding Retractor: named in the summary without a submission number

## Indications for use
The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.

Source page: https://510kreport.com/device/K993544
Methodology: https://510kreport.com/methodology