510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851612Substantially Equivalent

Derma Prep

Mowbray Co., Inc., Waterloo IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851612 is the FDA 510(k) clearance record for DERMA PREP, a class I device, cleared for Mowbray Co., Inc. on under FDA product code KGT (Drape, Adhesive, Aerosol). FDA records list one 510(k) clearance for Mowbray Co., Inc. As of , FDA records show no recalls naming K851612.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KGT Drape, Adhesive, Aerosol
Regulation
21 CFR 878.4380
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Mowbray Co., Inc. 720 Broadway, Waterloo IA
Third party review
No

Clearances, product code KGT

Trailing 12 months

FDA records hold no clearances under product code KGT in the trailing twelve months.

FDA records show no clearances under product code KGT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260