510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K863865Substantially Equivalent

Tensotape Surgical Adhesive Tape

Smith & Nephew, Inc., Massillon OH / Traditional, Substantially Equivalent

K863865 is the FDA 510(k) clearance record for TENSOTAPE SURGICAL ADHESIVE TAPE, cleared for Smith & Nephew, Inc. on . FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K863865.

Clearance record

Decision date
Received
(42 days to decision)
Review panel
Unknown
Applicant
Smith & Nephew, Inc. 1875 Harsh Ave. SE, Massillon OH
Third party review
No