Cleared Traditional

K872165 - ELASTO-GEL OCCLUSIVE DRESSING

K872165 · Southwest Technologies, Inc. · General & Plastic Surgery device

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Jun 1987

Decision

21d

Days

Risk

K872165 is an FDA 510(k) clearance for the ELASTO-GEL OCCLUSIVE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Southwest Technologies, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 26, 1987 after a review of 21 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 Southwest Technologies, Inc. devices

Submission Details

510(k) Number	K872165 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	June 05, 1987
Decision Date	June 26, 1987
Days to Decision	21 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

94d faster than avg

Panel avg: 115d · This submission: 21d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 222

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K872165.

INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING

K872624 · Smith & Nephew, Inc. · Jul 1987

CUTINOVA(R) PLUS FOAM GELFILM

K864913 · Beiersdorf, Inc. · Jul 1987

AMERICAN PHARMASEAL WOUND DRESSING

K871770 · American Pharmaseal Div. Ahsc · Jun 1987

VISCOPASTE ZINC PASTE BANDAGE

K863930 · Smith & Nephew, Inc. · Dec 1986

CHESEBROUGH POND'S HYDROCOLLOID DRESSING

K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986

HYDROCOLLOID DRESSINGS - STERILE

K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986

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 K872165

Southwest Technologies, Inc.

Kansas City, MO · US

EDWARD I STOUT

Regulatory profile

5 submissions 3 cleared

60% 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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