Cleared Traditional

K935096 - BIOLEX IMPREGNATED WOUND DRESSING

K935096 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
118d
Days
-
Risk

K935096 is an FDA 510(k) clearance for the BIOLEX IMPREGNATED WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 118 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.

FDA 510(k) Submission Details - K935096

510(k) Number K935096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1993
Decision Date February 17, 1994
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K935096.
STERILE WOUND HYDROGEL DRESSING
K941339 · Renaissance Pharmaceutical, Inc. · Jun 1994
HYDRO-M(TM) WOUND GEL
K940814 · Kingston Technologies, Inc. · May 1994
FLOWGEL(R) TOPICAL WOUND DRESSING
K926353 · Mediventures, Inc. · Feb 1994
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K935203 · Renaissance Medical, Inc. · Jan 1994
MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS)
K933495 · Marketing Professionals IN Medicine, Inc. · Jan 1994
ROYL-DERM WOUND HYDROGEL DRESSING
K932973 · Renaissance Medical, Inc. · Jan 1994
K935096 · BIOLEX IMPREGNATED WOUND DRESSING
Download PDF FDA Summary C.R. Bard, Inc.