Cleared Traditional

K812711 - STERILE GAUZE PADS 12PLY

K812711 is an FDA 510(k) clearance for STERILE GAUZE PADS 12PLY, manufactured by Medspec Corp.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K812711 · Medspec Corp. · General & Plastic Surgery device
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Nov 1981
Decision
39d
Days
Class 1
Risk

K812711 is an FDA 510(k) clearance for the STERILE GAUZE PADS 12PLY. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Medspec Corp. (Prospect Heights, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - the FDA general and plastic surgery device framework. 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 Medspec Corp. devices

FDA 510(k) Submission Details - K812711

510(k) Number K812711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1981
Decision Date November 02, 1981
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAB Gauze / Sponge,nonresorbable For External Use

All 34
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K812711.
SHEET WADDING CAST PADDING
K820097 · Stan-Pak Ent. · Feb 1982
ROLLER GAUZE
K820098 · Stan-Pak Ent. · Feb 1982
COMFORT CUSHION DRY BURN PAD III
K813419 · American Convertors Div., American Pharmaseal · Jan 1982
TRIANGULAR BANDAGE
K811814 · Abco Dealers, Inc. · Jul 1981
BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
GUAZE BANDAGES CAT.#101-169
K801996 · Pollak (Intl.), Ltd. · Sep 1980