K863563Substantially Equivalent

Uresil Radiopaque Silicone Bands

Name: K863563 Uresil Radiopaque Silicone Bands
Creator: Uresil Corp.
Published: 1986-10-02
License: https://open.fda.gov/license/

Uresil, LLC, Skokie IL / Traditional, Substantially Equivalent

FDA source

K863563 is the FDA 510(k) clearance record for URESIL RADIOPAQUE SILICONE BANDS, cleared for Uresil Corp. on 1986-10-02. FDA records list 49 510(k) clearances for Uresil Corp., from 1981-10-02 to 2010-02-23. As of 2026-09-10, FDA records show no recalls naming K863563.

Clearance record

Decision date: 1986-10-02
Received: 1986-09-12 (20 days to decision)
Review panel: Unknown
Applicant: Uresil Corp. 5418 W. Touhy Ave., Skokie IL
Third party review: No