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510(k) K000936

VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM by Mitek Products — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2000
Date Received
March 23, 2000
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 Mitek Products

  • K013572 — MITEK BIOCRYL INTERFERENCE SCREWS (March 14, 2002)
  • K013781 — RIDIDFIX 2.7MM BTB CROSS PIN KIT (February 6, 2002)
  • K002639 — BIOKNOTLESS ANCHOR (May 11, 2001)
  • K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM (May 9, 2001)
  • K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM (February 15, 2001)
  • K003076 — MITEK CUFFTACK (October 27, 2000)
  • K002422 — VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM (August 31, 2000)
  • K002402 — VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM (August 31, 2000)
  • K993575 — RESOLVE QUICKANCHOR (December 29, 1999)
  • K993327 — TALON ANCHOR SNAP-PAK (December 16, 1999)

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