Cleared Traditional

K973688 - DUODERM CONTROL GEL FORMULA BORDER DRESSING

K973688 · Convatec, Ltd. · General & Plastic Surgery device

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Dec 1997

Decision

88d

Days

Risk

K973688 is an FDA 510(k) clearance for the DUODERM CONTROL GEL FORMULA BORDER DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, Ltd. (Skillman, US). The FDA issued a Cleared decision on December 23, 1997 after a review of 88 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 Convatec, Ltd. devices

FDA 510(k) Submission Details - K973688

510(k) Number	K973688 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	September 26, 1997
Decision Date	December 23, 1997
Days to Decision	88 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

27d faster than avg

Panel avg: 115d · This submission: 88d

Pathway characteristics

Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 576

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K973688.

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

K980777 · Dumex Medical Surgical Products, Ltd. · May 1998

20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE

K972185 · Steripak, Ltd. · Mar 1998

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING

K974348 · Laboratoires Urgo S.A. · Feb 1998

DUODERM HYDROACTIVE DRESSING

K973689 · Convatec, Ltd. · Dec 1997

DUODERM HYDROACTIVE PASTE

K973807 · Convatec, A Bristol-Myers Squibb Co. · Dec 1997

DUODERM CGF CONTROL GEL FORMULA DRESSING

K973632 · Convatec, A Division of E.R. Squibb & Sons · Dec 1997

FDA 510(k) Resources - General & Plastic Surgery

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

Manufacturer of K973688

Convatec, Ltd.

Skillman, NJ · US

ANDRIENNE MCNALLY

Regulatory profile

4 submissions 2 cleared

50% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: December 23, 1997. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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