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Episealer Patellofemoral System

by Episurf Medical, Inc. 510(k)

Active United States

510(k) K221048

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221048 Date23 Dec 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KRR
Device Class
Class II
Regulation
21 CFR Part 888.3540
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent