Cleared Traditional

K812651 - X-RAY DETECTABLE LAP SPONGES

K812651 is an FDA 510(k) clearance for X-RAY DETECTABLE LAP SPONGES, manufactured by Procter & Gamble Mfg. Co.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K812651 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device
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Oct 1981
Decision
33d
Days
Class 1
Risk

K812651 is an FDA 510(k) clearance for the X-RAY DETECTABLE LAP SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4450 - 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 Procter & Gamble Mfg. Co. devices

FDA 510(k) Submission Details - K812651

510(k) Number K812651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1981
Decision Date October 20, 1981
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
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 - GDY Gauze/sponge, Internal, X-ray Detectable

All 57
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K812651.
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · American Medical Disposable, Inc. · Feb 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · American Medical Disposable, Inc. · Feb 1983
PARKE-DAVIS AEGIS ABOSRBENT SPONGES
K813595 · Deseret Medical, Inc. · Jan 1982
TOMAC STERILE DISP. LAP SPONGE
K812554 · American Convertors Div., American Pharmaseal · Sep 1981
GAUZE SPONGES
K803188 · Abco Dealers, Inc. · Jan 1981
OPRATEX ABDOMINAL PAD
K802798 · Secol Co. · Dec 1980