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FDA 510(k)

EvaQMax Smoke Evacuation System

K-Number: K192035 · 2019-08-29

ApplicantBio Protech, Inc.
Decision Date2019-08-29
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EvaQMax Smoke Evacuation System is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K192035. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EvaQMax Smoke Evacuation System?

EvaQMax Smoke Evacuation System is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Bio Protech, Inc.. The 510(k) number is K192035.

When did EvaQMax Smoke Evacuation System receive FDA 510(k) clearance?

EvaQMax Smoke Evacuation System received FDA 510(k) clearance on 2019-08-29, under 510(k) number K192035.

Who is the listed applicant for EvaQMax Smoke Evacuation System?

The FDA 510(k) record lists Bio Protech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EvaQMax Smoke Evacuation System?

The FDA product code for EvaQMax Smoke Evacuation System is FYD.

Other records listing Bio Protech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesK153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

Related Devices (Code: FYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K191328Megadyne Foot SwitchMegadyne Medical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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