Cleared Traditional

K935911 - PACKING SPONGE

K935911 · Mcneil Healthcare, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
53d
Days
-
Risk

K935911 is an FDA 510(k) clearance for the PACKING SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Mcneil Healthcare, Inc. (Waterford, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 53 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 Mcneil Healthcare, Inc. devices

FDA 510(k) Submission Details - K935911

510(k) Number K935911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1993
Decision Date January 31, 1994
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
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 85
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K935911.
ISOLYER (4X4, 12 PLY)
K940754 · Thantex Specialties, Inc. · May 1994
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
SERENE WRAP
K895865 · Byron Medical · Dec 1989
LAP SPONGE
K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989