Cleared Traditional

K973538 - N-TERFACE

K973538 · Winfield Laboratories, Inc. · General & Plastic Surgery device
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Dec 1997
Decision
89d
Days
-
Risk

K973538 is an FDA 510(k) clearance for the N-TERFACE. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Winfield Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 89 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 Winfield Laboratories, Inc. devices

FDA 510(k) Submission Details - K973538

510(k) Number K973538 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 18, 1997
Decision Date December 16, 1997
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

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