Home / 510(k) Clearances / K161134

510(k) K161134

Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator by Bovie Medical Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2016
Date Received
April 22, 2016
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 Bovie Medical Corporation

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  • K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Elec (March 8, 2017)
  • K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie (July 29, 2016)
  • K152777 — Bovie Disposable Bipolar Ablator (January 15, 2016)
  • K152570 — Bovie J-Plasma Precise 360 Handpiece (November 2, 2015)
  • K151325 — Bovie J-Plasma Handpiece (August 4, 2015)
  • K142975 — Bovie Ultimate High Frequency Electrosurgical Generator (December 12, 2014)
  • K134054 — BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUEN (March 17, 2014)
  • K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FIN (July 20, 2012)

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