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510(k) K191328

Megadyne Foot Switch by Megadyne Medical Products, Inc. — Product Code FYD

K191328 is an FDA 510(k) premarket notification submitted by Megadyne Medical Products, Inc. for the device "Megadyne Foot Switch". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Megadyne Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
May 16, 2019
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)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (March 24, 2020)
  • 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)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K192035 — EvaQMax Smoke Evacuation System (August 29, 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)

FDA data resources