Cleared Traditional

EPIVIEW (K940895) - FDA 510(k) Clearance

K940895 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
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Nov 1994
Decision
271d
Days
-
Risk

K940895 is an FDA 510(k) clearance for the EPIVIEW. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Convatec, A Bristol-Myers Squibb Co. (Skillman, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 271 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec, A Bristol-Myers Squibb Co. devices

Submission Details

510(k) Number K940895 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 24, 1994
Decision Date November 22, 1994
Days to Decision 271 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 115d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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