Cleared Traditional

K822058 - GELIPERM TRANSPARENT GEL-FILM DRESSING

K822058 · Hamel, Park, Mccabe & Saunders · General & Plastic Surgery device
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Aug 1983
Decision
395d
Days
-
Risk

K822058 is an FDA 510(k) clearance for the GELIPERM TRANSPARENT GEL-FILM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hamel, Park, Mccabe & Saunders (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hamel, Park, Mccabe & Saunders devices

Submission Details

510(k) Number K822058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1982
Decision Date August 12, 1983
Days to Decision 395 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
280d slower than avg
Panel avg: 115d · This submission: 395d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 224
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K822058.
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
NON - ADHERENT BANDAGE
K833733 · American Medical Disposable, Inc. · Dec 1983
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · Convatec, A Division of E.R. Squibb & Sons · May 1983
CONVERTORS PRIMARY WOUND DRESSING II
K822990 · American Hospital Supply Corp. · Apr 1983
PERFILM MEMBRANE DRESSING
K822467 · Chesebrough-Pond'S U.S.A. Co. · Dec 1982