Home / 510(k) Clearances / K200250

510(k) K200250

Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor by Megadyne Medical Products, Inc. — Product Code FYD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 26, 2020
Date Received: February 3, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Apparatus, Exhaust, Surgical
Device Class: Class II
Regulation Number: 878.5070
Review Panel: HO
Submission Type

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)
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)

Other clearances for product code FYD

K240127 — PlumeSafe X5 Smoke Management System (August 5, 2024)
K233789 — 8Q10 Surclear Smoke Plume Evacuation System (April 10, 2024)
K213068 — Medline Smoke Evacuation Shroud (January 3, 2022)
K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System (March 25, 2021)
K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
K191328 — Megadyne Foot Switch (July 26, 2019)
K182224 — SafeAir Smoke Evacuator compact (February 7, 2019)
K173108 — Smoklean (May 18, 2018)
K163659 — Crystal Vision (October 30, 2017)
K142335 — RapidVac Smoke Evacuator System (January 14, 2015)