Cleared Traditional

K926034 - EPI-LOCK WOUND DRESSING

K926034 · Calgon Vestal Div. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
140d
Days
-
Risk

K926034 is an FDA 510(k) clearance for the EPI-LOCK WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 140 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 Calgon Vestal Div. devices

FDA 510(k) Submission Details - K926034

510(k) Number K926034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date April 20, 1993
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 19
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K926034.
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · The Kendal Co. · Jul 1994
CUTIFILM(R) FILM
K926399 · Beiersdorf, Inc. · Nov 1993
HYDRASORB STERILE DRESSING
K931599 · Calgon Vestal Div. · Jul 1993
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992
PROCEL BURN COVER
K915695 · W.L. Gore & Associates, Inc. · May 1992
CURITY VENTED DRESSING SYSTEM
K915635 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1992