510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954230Substantially Equivalent

Sorbsan Plus Topical Wound Dressing

Dow Hickam Pharmaceuticals, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954230 is the FDA 510(k) clearance record for SORBSAN PLUS TOPICAL WOUND DRESSING, a class I device, cleared for Dow Hickam Pharmaceuticals, Inc. on under FDA product code KMF (Bandage, Liquid). FDA records list 2 510(k) clearances for Dow Hickam Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K954230.

Clearance record

Decision date
Received
(58 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Dow Hickam Pharmaceuticals, Inc. 10410 Corporate Dr., Sugar Land TX
510(k) summary
Summary
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

FDA records show no clearances under product code KMF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMF, 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