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ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK - Uc-8

by Epicor Medical, Inc. 510(k)

Active United States

510(k) K040641

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040641 Date5 May 2004ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NTB
Models / Variants
Uc-8
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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