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510(k) K233644

Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) by Megadyne Medical Products, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2024
Date Received
November 13, 2023
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 Megadyne Medical Products, Inc.

  • K213696 — ETHICON Megadyne Electrosurgical Generator (January 21, 2022)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (March 24, 2020)
  • K191328 — Megadyne Foot Switch (July 26, 2019)
  • K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA F (February 18, 2015)
  • K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE (January 24, 2014)
  • K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (December 16, 2008)
  • K081791 — E-Z CLEAN ELECTROSURGICAL ELECTRODE (October 21, 2008)
  • K072559 — SUCTION COAGULATOR (October 5, 2007)
  • K050579 — MEGA POWER ELECTROSURGICAL GENERATOR (March 24, 2005)

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