K862583Substantially Equivalent

Lite Touch Gelfoam Insert

Name: K862583 Lite Touch Gelfoam Insert
Creator: Treace Medical, Inc.
Published: 1986-07-21
License: https://open.fda.gov/license/

Treace Medical, Inc., Memphis TN / Traditional, Substantially Equivalent

FDA source

K862583 is the FDA 510(k) clearance record for LITE TOUCH GELFOAM INSERT, cleared for Treace Medical, Inc. on 1986-07-21. FDA records list 80 510(k) clearances for Treace Medical, Inc., from 1982-09-02 to 1989-01-13. As of 2026-09-10, FDA records show no recalls naming K862583.

Clearance record

Decision date: 1986-07-21
Received: 1986-07-07 (14 days to decision)
Review panel: Unknown
Applicant: Treace Medical, Inc. Suite 400, Memphis TN
Third party review: No