Cleared Traditional

K950906 - LESINSKI SURGICAL EAR DRESSING

K950906 · Microtek Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
114d
Days
-
Risk

K950906 is an FDA 510(k) clearance for the LESINSKI SURGICAL EAR DRESSING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Microtek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 114 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 Microtek Medical, Inc. devices

FDA 510(k) Submission Details - K950906

510(k) Number K950906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1995
Decision Date June 22, 1995
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K950906.
PROTEC ROLL GAUZE
K960093 · Derivadas Degasa S.A. DE C.V. · Mar 1996
SYNTHETIC SPONGE
K955165 · Igenics, Inc. · Feb 1996
GENERAL USE SYNTHETIC SPONGE (STERILE)
K955527 · Igenics, Inc. · Feb 1996
DYNAREX GAUZE SPONGE
K951660 · Dynarex Corp. · May 1995
1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
K945002 · Certified Safety Mfg., Inc. · Mar 1995
2, 3 & 4 BANDADGE COMPRESS
K945004 · Certified Safety Mfg., Inc. · Mar 1995