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Disk Whisk Cutting Device (Conical, Elliptical and Ball Head)

by Disk Whisk, Inc. 510(k)

Active United States

510(k) K971342

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971342 Date8 Jul 1997ClearedStatusActive

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  • Withdrawn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
HWE
Device Class
Class I
Regulation
21 CFR Part 878.4820
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent