K863604Substantially Equivalent

Disposable Blades for Arthroscopic Surgical Device

Name: K863604 Disposable Blades for Arthroscopic Surgical Device
Creator: American Edwards Laboratories
Published: 1986-10-03
License: https://open.fda.gov/license/

American Edwards Laboratories, Santa Ana CA / Traditional, Substantially Equivalent

FDA source

K863604 is the FDA 510(k) clearance record for DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE, cleared for American Edwards Laboratories on 1986-10-03. FDA records list 89 510(k) clearances for American Edwards Laboratories, from 1980-11-26 to 1987-12-03. As of 2026-09-10, FDA records show no recalls naming K863604.

Clearance record

Decision date: 1986-10-03
Received: 1986-09-16 (17 days to decision)
Review panel: Unknown
Applicant: American Edwards Laboratories P.O. Box 11150, Santa Ana CA
Third party review: No