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FDA 510(k)

NEBULAE SRS Laparoscopic Surgical Smoke Removal System

K-Number: K202944 · 2021-03-25

ApplicantNorthgate Technologies, Inc.
Decision Date2021-03-25
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEBULAE SRS Laparoscopic Surgical Smoke Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K202944. 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 NEBULAE SRS Laparoscopic Surgical Smoke Removal System?

NEBULAE SRS Laparoscopic Surgical Smoke Removal System is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K202944.

When did NEBULAE SRS Laparoscopic Surgical Smoke Removal System receive FDA 510(k) clearance?

NEBULAE SRS Laparoscopic Surgical Smoke Removal System received FDA 510(k) clearance on 2021-03-25, under 510(k) number K202944.

Who is the listed applicant for NEBULAE SRS Laparoscopic Surgical Smoke Removal System?

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

What is the FDA product code for NEBULAE SRS Laparoscopic Surgical Smoke Removal System?

The FDA product code for NEBULAE SRS Laparoscopic Surgical Smoke Removal System is FYD.

Other records listing Northgate Technologies, 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.

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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.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, 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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