Cleared Traditional

K811951 - DRESSING CHANGE TRAYS & STERILE SPONGES

K811951 · O.R. Specialties, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
101d
Days
-
Risk

K811951 is an FDA 510(k) clearance for the DRESSING CHANGE TRAYS & STERILE SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by O.R. Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 16, 1981 after a review of 101 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 O.R. Specialties, Inc. devices

Submission Details

510(k) Number K811951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1981
Decision Date October 16, 1981
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 39
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K811951.
STERILE LAPAROTOMY GAUZE SPONGE
K862126 · Anago, Inc. · Jun 1986
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982
SOFTCARE BARRIER WET DRESSING
K812736 · The Kendal Co. · Nov 1981
POST OP. SPONGES STERILE
K802860 · Abco Dealers, Inc. · Dec 1980
COMBINATION PADS STERILE SINGLES
K802861 · Abco Dealers, Inc. · Dec 1980
GAUZE PADS STERILE SINGLES
K802862 · Abco Dealers, Inc. · Dec 1980