Cleared Traditional

K812651 - X-RAY DETECTABLE LAP SPONGES (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 114d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.