Cleared Traditional

K940574 - TENDERBREDE PACKING AND DEBRIDEMENT SPONGE

K940574 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
71d
Days
-
Risk

K940574 is an FDA 510(k) clearance for the TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 20, 1994 after a review of 71 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K940574

510(k) Number K940574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date April 20, 1994
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 109
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K940574.
ISOLYSER
K940765 · Thantex Specialties, Inc. · Dec 1994
STERILE GAUZE PRODUCT LINE
K941455 · Cush Medical Products · May 1994
ISOLYER (4X4, 12 PLY)
K940754 · Thantex Specialties, Inc. · May 1994
VISITEC EYE PAD
K940210 · Visitec Co. · Mar 1994
NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING
K935930 · Mcneil Healthcare, Inc. · Feb 1994
PACKING SPONGE
K935911 · Mcneil Healthcare, Inc. · Jan 1994