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510(k) K180848

AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches by ArthroCare Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2018
Date Received
April 2, 2018
Clearance Type
Special
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

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  • K220563 — Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System (September 1, 2022)
  • K210423 — Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostas (June 24, 2021)
  • 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)
  • K172165 — Q-Fix Suture Anchor (August 17, 2017)
  • K163142 — SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cob (January 6, 2017)

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