Episealer Patellofemoral System— 510(k) K221048

Name: FDA 510(k) clearance K221048
Creator: U.S. Food and Drug Administration
Published: 2022-12-23

Substantially Equivalent

Episurf Medical, Inc.

FDA 510(k) clearance K221048 for Episealer Patellofemoral System, Substantially Equivalent on 2022-12-23. Applicant: Episurf Medical, Inc.. Device class: 2.

Clearance details

Applicant: Episurf Medical, Inc.
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2022-04-08
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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