GELIPERM GRANULES— 510(k) K823225

Name: FDA 510(k) clearance K823225
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Geistlich-Pharma

FDA 510(k) clearance K823225 for GELIPERM GRANULES, Substantially Equivalent on 1983-08-12. Applicant: Geistlich-Pharma. Device class: Unclassified.

Clearance details

Applicant: Geistlich-Pharma
Product code: Product code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1982-10-29
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Geistlich-Pharma

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K033815 — BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN2004-01-15
K014289 — ORTHOSS RESORBABLE BONE VOID FILLER2002-03-28
K970569 — BIO-BLOCKS2000-08-14
K974399 — BIO-OSS COLLAGEN1998-09-16
K970321 — BIO-OSS ANORGANIC BOVINE BONE1998-09-15

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.