Cleared Traditional

K961319 - EPIVIEW

K961319 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
94d
Days
-
Risk

K961319 is an FDA 510(k) clearance for the EPIVIEW. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on July 8, 1996 after a review of 94 days - within the typical 510(k) review window.

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 Division of E.R. Squibb & Sons devices

FDA 510(k) Submission Details - K961319

510(k) Number K961319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1996
Decision Date July 08, 1996
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
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

All 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K961319.
ALGOPLAQUE HYDROCOLLOID DRESSING
K970518 · Laboratoires Urgo S.A. · Mar 1997
NASP TRANSPARENT DRESSING
K963753 · North American Sterilization & Packaging Co. · Nov 1996
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · Polymedica Industries, Inc. · Oct 1996
BIO-DRESSING, STERILE ISLAND DRESSING
K961098 · K. W. Griffen Co. · May 1996
DERMASEAL
K960847 · Bellingham Medical, Inc. · Apr 1996
SURESKIN BORDER
K960393 · Euromed A/S · Mar 1996