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FDA 510(k)

GEM Biover Microvascular Clamps

K-Number: K221843 · 2022-09-14

ApplicantSynovis Micro Companies Alliance, Inc.
Decision Date2022-09-14
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEM Biover Microvascular Clamps is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K221843. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Biover Microvascular Clamps?

GEM Biover Microvascular Clamps is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Synovis Micro Companies Alliance, Inc.. The 510(k) number is K221843.

When did GEM Biover Microvascular Clamps receive FDA 510(k) clearance?

GEM Biover Microvascular Clamps received FDA 510(k) clearance on 2022-09-14, under 510(k) number K221843.

Who is the listed applicant for GEM Biover Microvascular Clamps?

The FDA 510(k) record lists Synovis Micro Companies Alliance, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM Biover Microvascular Clamps?

The FDA product code for GEM Biover Microvascular Clamps is DXC.

Other records listing Synovis Micro Companies Alliance, 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: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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