Cleared Traditional

K811951 - DRESSING CHANGE TRAYS & STERILE SPONGES

K811951 · O.R. Specialties, Inc. · General & Plastic Surgery device
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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

FDA 510(k) Submission Details - K811951

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.

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 K811951.
GUAZE SPONGES, PLAIN
K820107 · Stan-Pak Ent. · Feb 1982
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · American Convertors Div., American Pharmaseal · Dec 1981
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