MEDIFIL— 510(k) K910944

Name: FDA 510(k) clearance K910944
Creator: U.S. Food and Drug Administration
Published: 1991-04-02

Substantially Equivalent

Biocore

FDA 510(k) clearance K910944 for MEDIFIL, Substantially Equivalent on 1991-04-02. Applicant: Biocore. Device class: Unclassified.

Clearance details

Applicant: Biocore
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 1991-03-06
Decision date: 1991-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Topeka, KS, US

Download summary PDF View on FDA.gov ↗

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K260596 — Collagen Wound Powder2026-07-02
K260669 — Endoform Dermal Template2026-06-24
K253521 — ECMT-100 WMD2026-06-18

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K925545 — SKINTEMP, MODIFICATION1993-02-23
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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.