Cleared Traditional

K050842 - AGCEL WOUND DRESSING,AGCEL BURN DRESSING

K050842 · Modern Medical Equipment Mfg., Ltd. · General & Plastic Surgery device
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Aug 2006
Decision
488d
Days
-
Risk

K050842 is an FDA 510(k) clearance for the AGCEL WOUND DRESSING,AGCEL BURN DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Modern Medical Equipment Mfg., Ltd. (Richmond, US). The FDA issued a Cleared decision on August 2, 2006 after a review of 488 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Modern Medical Equipment Mfg., Ltd. devices

FDA 510(k) Submission Details - K050842

510(k) Number K050842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date August 02, 2006
Days to Decision 488 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
373d slower than avg
Panel avg: 115d · This submission: 488d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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