KGTClass I

Drape, Adhesive, Aerosol

General, Plastic Surgery · 21 CFR 878.4380

MDR events5All time

Recalls1All time

Registered firms28Currently listed

510(k) clearances1All time

Recent MDR events

5 adverse event reports on file

Event type breakdown

Malfunction2

Other2

Injury1

Most-reported manufacturers

Cardinal Health3 Novo Health Services2

Recalls

1 recall events for this product code

Kapp Surgical Instrument Inc
TerminatedOct 19, 2011
STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are pl
A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.
Z-0068-2012 · View FDA record ↗

Registered firms

28 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Mowbray Co., Inc.May 3, 1985
K851612 · DERMA PREP