Cleared Traditional

K792628 - STERILIZATION PROCESS/VAGINAL SPONGE

K792628 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device

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Jan 1980

Decision

23d

Days

Risk

K792628 is an FDA 510(k) clearance for the STERILIZATION PROCESS/VAGINAL SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 23 days - a notably fast clearance cycle.

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: 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	K792628 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 19, 1979
Decision Date	January 11, 1980
Days to Decision	23 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

92d faster than avg

Panel avg: 115d · This submission: 23d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	EFQ Gauze/sponge, Internal
Device Class	-

Regulatory Peers - EFQ Gauze/sponge, Internal

All 23

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K792628.

GAUZE PADS STERILE SINGLES

K802862 · Abco Dealers, Inc. · Dec 1980

GAUZE SPONGES

K802863 · Abco Dealers, Inc. · Dec 1980

STORZ SUPER SORB MICRO EYE SPONGE

K800082 · Storz Instrument Co. · Feb 1980

LAPOROTOMY SPONGE

K780806 · Abco Dealers, Inc. · Jun 1978

SPONGE, LAPAROTOMY GAUZE

K760113 · Parke-Davis Co. · Jul 1976

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K792628

Procter & Gamble Mfg. Co.

Mchenry, IL · US

Regulatory profile

72 submissions 72 cleared

100% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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