510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K970453Substantially Equivalent for Some Indications

B. Braun Medical Inc. Transorbent and Thinsite Border Dressing

B.Braun Medical, Inc., Milwaukee WI / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K970453 is the FDA 510(k) clearance record for B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING, cleared for B.Braun Medical, Inc. on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K970453.

Clearance record

Decision date
Received
(79 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
B.Braun Medical, Inc. 727 W. Glendale Ave., Milwaukee WI
Third party review
No

Clearances, product code MGQ

Trailing 12 months

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

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