GELIPERM DRY— 510(k) K822073

Name: FDA 510(k) clearance K822073
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Hamel, Park, Mccabe & Saunders

FDA 510(k) clearance K822073 for GELIPERM DRY, Substantially Equivalent on 1983-08-12. Applicant: Hamel, Park, Mccabe & Saunders. Device class: Unclassified.

Clearance details

Applicant: Hamel, Park, Mccabe & Saunders
Product code: Product code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1982-07-15
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

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K260285 — Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz)2026-10-26
K254168 — Actolind® (06.3637. Actolind® Gel Plus)2026-09-22
K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11

More clearances from Hamel, Park, Mccabe & Saunders

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K822058 — GELIPERM TRANSPARENT GEL-FILM DRESSING1983-08-12
K822315 — GFB-B CONTACT LENS BLANKS1982-11-16

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.