Cleared Traditional

K950404 - LOCKETT MEDICAL CORP. GAUZE

K950404 · Lockett Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
76d
Days
-
Risk

K950404 is an FDA 510(k) clearance for the LOCKETT MEDICAL CORP. GAUZE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Lockett Medical Corp. (Providence, US). The FDA issued a Cleared decision on April 17, 1995 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lockett Medical Corp. devices

FDA 510(k) Submission Details - K950404

510(k) Number K950404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date April 17, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
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 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K950404.
GENERAL USE SYNTHETIC SPONGE (STERILE)
K955527 · Igenics, Inc. · Feb 1996
LESINSKI SURGICAL EAR DRESSING
K950906 · Microtek Medical, Inc. · Jun 1995
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
OREX
K940716 · Thantex Specialties, Inc. · Dec 1994