Cleared Traditional

AMBU GEL, HYDROGEL BURN DRESSING (K010583) - FDA 510(k) Clearance

K010583 · Ambu, Inc. · General & Plastic Surgery device
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May 2001
Decision
87d
Days
-
Risk

K010583 is an FDA 510(k) clearance for the AMBU GEL, HYDROGEL BURN DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on May 25, 2001 after a review of 87 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 Ambu, Inc. devices

Submission Details

510(k) Number K010583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2001
Decision Date May 25, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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

Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K010583.
TENDERWET ACTIVE
K040517 · Medline Industries, Inc. · Mar 2004
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SOLOSITE GEL CONFORMABLE DRESSING
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B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994