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FDA 510(k)

GEM FLOW COUPLER DEVICE AND SYSTEM

K-Number: K132727 · 2013-10-22

ApplicantSynovis Life Technologies, Inc.
Decision Date2013-10-22
Product CodeMVR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GEM FLOW COUPLER DEVICE AND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2013-10-22 under 510(k) number K132727. The device is classified under product code MVR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM FLOW COUPLER DEVICE AND SYSTEM?

GEM FLOW COUPLER DEVICE AND SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-22. The listed applicant is Synovis Life Technologies, Inc.. The 510(k) number is K132727.

When did GEM FLOW COUPLER DEVICE AND SYSTEM receive FDA 510(k) clearance?

GEM FLOW COUPLER DEVICE AND SYSTEM received FDA 510(k) clearance on 2013-10-22, under 510(k) number K132727.

Who is the listed applicant for GEM FLOW COUPLER DEVICE AND SYSTEM?

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

What is the FDA product code for GEM FLOW COUPLER DEVICE AND SYSTEM?

The FDA product code for GEM FLOW COUPLER DEVICE AND SYSTEM is MVR.

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Other records listing Synovis Life 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.

K223052Peri-Guard and Supple Peri-GuardK221032Vascu-Guard Vascular Repair PatchK221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchK130896VASCULAR PROBE, VASCULAR PROBE ES

Related Devices (Code: MVR)

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.

K190499Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.K191252Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.K093310GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Micro Companies Alliance, Inc.K090679VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEMVioptix, Inc.K040163MICROVASCULAR ANASTOMOTIC DEVICESynovis Micro Companies Alliance, Inc.K8619853M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)3M Company

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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