Home / 510(k) Clearances / K210423

510(k) K210423

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand by ArthroCare Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2021
Date Received
February 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by ArthroCare Corporation

  • K240964 — FLOW 90? Wand (May 8, 2024)
  • K232290 — INTELLIO SHIFT System (December 11, 2023)
  • K230914 — ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (June 26, 2023)
  • K220563 — Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System (September 1, 2022)
  • K202006 — ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Ad (December 18, 2020)
  • K192027 — WEREWOLF COBLATION System, COBLATION HALO Wand (December 20, 2019)
  • K183346 — FLOW 90 Wand (January 24, 2019)
  • K180848 — AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches (May 1, 2018)
  • K172165 — Q-Fix Suture Anchor (August 17, 2017)
  • K163142 — SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cob (January 6, 2017)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)