# K921227: Tencel Topical Wound Dressing/Surgical Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Courtaulds Fibers, Inc.
- Decided: May 29, 1992 after 77 days
- Product code: NAB (Gauze / Sponge,Nonresorbable For External Use)
- Device class: 1
- Regulation: 21 CFR 878.4014
- 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 no predicate by number.

Source page: https://510kreport.com/device/K921227
Methodology: https://510kreport.com/methodology