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510(k) K200169

VFS1 Bipolar Electrosurgical Generator by FHC, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2020
Date Received
January 23, 2020
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 FHC, Inc.

  • K231141 — STarFix Designer Software C0265 (September 8, 2023)
  • K183123 — microTargeting Guideline 4000 5.0 System (December 20, 2018)
  • K121950 — MICROTARGETING XL STAR DRIVE SYSTEM (July 26, 2012)
  • K092192 — WAYPOINT STEREOTACTIC SYSTEM (February 12, 2010)
  • K092562 — MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS (September 18, 2009)
  • K071364 — MICROTARGETING GUIDELINE 4000 (July 25, 2007)
  • K033173 — MICRO TARGETING ELECTRODE (March 24, 2004)
  • K011775 — MICRO TARGETING DRIVE SYSTEM (August 30, 2001)
  • K011992 — FHC MICROTARGETING DRIVE SYSTEM (August 14, 2001)
  • K003776 — MICROTARGETING DRIVE SYSTEM (February 23, 2001)

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