Cleared Traditional

K941455 - STERILE GAUZE PRODUCT LINE

K941455 · Cush Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
56d
Days
-
Risk

K941455 is an FDA 510(k) clearance for the STERILE GAUZE PRODUCT LINE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on May 20, 1994 after a review of 56 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 Cush Medical Products devices

FDA 510(k) Submission Details - K941455

510(k) Number K941455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 25, 1994
Decision Date May 20, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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 48
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K941455.
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · Smith & Nephew United, Inc. · Jul 1996
LESINSKI SURGICAL EAR DRESSING
K950906 · Microtek Medical, Inc. · Jun 1995
TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE
K940574 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1994
VISITEC EYE PAD
K940210 · Visitec Co. · Mar 1994
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · Johnson & Johnson Medical, Inc. · Sep 1992