Gem Flow Now (GEM2770-FN)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233394

by Synovis Micro Companies Alliance, Inc

Identifiers

510(k) Number: K233394 FDA 510(k)
FDA Product Code: IYN FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1550 FDA 510(k)
Regulation Number: 892.1550 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Gem Flow Now (GEM2770-FN) is a Class II ultrasound system. It is intended for monitoring blood flow in vessels.

This device is cleared under FDA 510(k) number K233394. It is manufactured by Synovis Micro Companies Alliance.

Frequently asked questions

What is the primary clinical application of the Gem Flow Now system?

The Gem Flow Now (GEM2770-FN) is a Class II ultrasound system specifically intended for the monitoring of blood flow within vessels.

What is the regulatory status of this ultrasound device?

The Gem Flow Now system is cleared for use under FDA 510(k) number K233394, having been determined to be substantially equivalent to existing devices.

Who is the manufacturer of the Gem Flow Now GEM2770-FN?

This device is manufactured by Synovis Micro Companies Alliance, Inc., a subsidiary of Baxter International Inc., located in Birmingham, Alabama.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gem Flow Now (GEM2770-FN) (K233394) — FDA 510(k) | Innolitics, PDF January 28, 2024 Julie Carlston Senior Manager, Regulatory Affairs, Synovis Micro Companies Alliance Gem Flow Now (gem2770-FN)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K233394	Class II	Active

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Manufacturer

Manufacturer: Synovis Micro Companies Alliance, Inc
FDA Applicant: Synovis Micro Companies Alliance

Sources (1)

FDA 510(k) K233394 24 fields · synced Oct 6, 2026