510(k) K021077

MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD by Megadyne Medical Products, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 17, 2002
Date Received: April 3, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

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.

K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Pa (July 12, 2024)
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)

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