Cleared Traditional

K821150 - NU-GAUZE SPONGE

K821150 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Aug 1982
Decision
126d
Days
-
Risk

K821150 is an FDA 510(k) clearance for the NU-GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on August 27, 1982 after a review of 126 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K821150

510(k) Number K821150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1982
Decision Date August 27, 1982
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
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 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K821150.
FLORET GAUZE PACKING
K830278 · Ritmed, Inc. · Mar 1983
FLORET PEANUT SPONGE/STICK & GAUZE PREP
K830274 · Ritmed, Inc. · Mar 1983
DOSOMETRIC RELEASE STERILIZATION
K823058 · Stan-Pak Ent. · Dec 1982
X-RAY GUAZE SPONGES
K820106 · Stan-Pak Ent. · Feb 1982
GUAZE SPONGES, PLAIN
K820107 · Stan-Pak Ent. · Feb 1982
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · American Convertors Div., American Pharmaseal · Dec 1981