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FDA 510(k)

8Q10 Surclear Smoke Plume Evacuation System

K-Number: K233789 · 2024-04-10

ApplicantSurnic Corporation
Decision Date2024-04-10
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

8Q10 Surclear Smoke Plume Evacuation System is the device name listed in this FDA 510(k) record. The listed applicant is Surnic Corporation. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233789. 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 8Q10 Surclear Smoke Plume Evacuation System?

8Q10 Surclear Smoke Plume Evacuation System is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Surnic Corporation. The 510(k) number is K233789.

When did 8Q10 Surclear Smoke Plume Evacuation System receive FDA 510(k) clearance?

8Q10 Surclear Smoke Plume Evacuation System received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233789.

Who is the listed applicant for 8Q10 Surclear Smoke Plume Evacuation System?

The FDA 510(k) record lists Surnic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 8Q10 Surclear Smoke Plume Evacuation System?

The FDA product code for 8Q10 Surclear Smoke Plume Evacuation System is FYD.

Other records listing Surnic Corporation 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.

K203522Surn5 Electrosurgical Argon Beam Generator and Accessories

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 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.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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