Cleared Traditional

K040517 - TENDERWET ACTIVE

K040517 · Medline Industries, Inc. · General & Plastic Surgery device
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Mar 2004
Decision
27d
Days
-
Risk

K040517 is an FDA 510(k) clearance for the TENDERWET ACTIVE. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 25, 2004 after a review of 27 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.

FDA 510(k) Submission Details - K040517

510(k) Number K040517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2004
Decision Date March 25, 2004
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

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 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K040517.
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MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
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SINCLAIR WOUND AND SKIN EMULSION
K024367 · Sinclair Pharmaceuticals, Ltd. · Jul 2003
XYLOS XCELL ANTIMICROBIAL DRESSING
K024054 · Xylos Corporation · Mar 2003
K040517 · TENDERWET ACTIVE
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