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510(k) K192035

EvaQMax Smoke Evacuation System by Bio Protech, Inc. — Product Code FYD

K192035 is an FDA 510(k) premarket notification submitted by Bio Protech, Inc. for the device "EvaQMax Smoke Evacuation System". The FDA issued a decision of Substantially Equivalent on August 29, 2019. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Bio Protech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2019
Date Received
July 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Bio Protech, Inc.

  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (March 21, 2016)
  • K143103 — PROPENCIL Smoke Pencil (July 16, 2015)
  • K142099 — CUTANEOUS ELECTRODES (November 17, 2014)
  • K111270 — REUSABLE STIMULATING ELECTRODES (September 13, 2011)
  • K100246 — MAX-IF1000 (November 24, 2010)
  • K091248 — MAXEMS, MODELS 1000 AND 2000 (November 30, 2009)
  • K092732 — PROPENCIL ESU PENCIL (November 25, 2009)
  • K092761 — PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (November 24, 2009)
  • K083148 — TELECTRODE WET GEL ECG ELECTRODE (November 7, 2008)

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)
  • 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)

FDA data resources