Cleared Traditional

K792431 - VAGINAL PACKING

K792431 · American Medical Disposable, Inc. · General & Plastic Surgery device

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Dec 1979

Decision

29d

Days

Risk

K792431 is an FDA 510(k) clearance for the VAGINAL PACKING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979 after a review of 29 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 American Medical Disposable, Inc. devices

Submission Details

510(k) Number	K792431 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 28, 1979
Decision Date	December 27, 1979
Days to Decision	29 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

86d faster than avg

Panel avg: 115d · This submission: 29d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	EFQ Gauze/sponge, Internal
Device Class	-

Regulatory Peers - EFQ Gauze/sponge, Internal

All 42

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K792431.

TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPE

K792616 · American Medical Disposable, Inc. · Jan 1980

TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER

K792617 · American Medical Disposable, Inc. · Jan 1980

TRACHEOTOMY SPONGE, NON-WOVEN DELNET

K792618 · American Medical Disposable, Inc. · Jan 1980

BURN PAD, DRY, STERILE

K781985 · Chesebrough-Pond'S U.S.A. Co. · Dec 1978

LAPOROTOMY SPONGE

K780806 · Abco Dealers, Inc. · Jun 1978

INTERSORB LAPAROTOMY SPONGE

K761037 · Chesebrough-Pond'S U.S.A. Co. · Dec 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 K792431

American Medical Disposable, Inc.

Mchenry, IL · US

Regulatory profile

33 submissions 33 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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