Cleared Traditional

K970453 - B. BRAUN MEDICAL INC. TRANSORBENT AND T...

K970453 · B.Braun Medical, Inc. · General & Plastic Surgery device
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Apr 1997
Decision
79d
Days
-
Risk

K970453 is an FDA 510(k) clearance for the B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by B.Braun Medical, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 11, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K970453 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 22, 1997
Decision Date April 11, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 14
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K970453.
NU-GEL * WOUND DRESSING
K983362 · Johnson & Johnson Medical, Inc. · Dec 1998
SWEEN WOUN'DRES
K983042 · Coloplast Corp. · Nov 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1994