FDA 510(k)

Rhapsody H-30 Holmium Laser System

K-Number: K172325 · 2017-10-26

Decision Date2017-10-26

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Rhapsody H-30 Holmium Laser System is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-10-26 under approval number K172325. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rhapsody H-30 Holmium Laser System?

Rhapsody H-30 Holmium Laser System is a medical device that received FDA 510(k) clearance on 2017-10-26. It is manufactured by Cook Incorporated. The 510(k) number is K172325.

When was Rhapsody H-30 Holmium Laser System approved by the FDA?

Rhapsody H-30 Holmium Laser System received FDA 510(k) clearance on 2017-10-26, under approval number K172325.

What company makes Rhapsody H-30 Holmium Laser System?

Rhapsody H-30 Holmium Laser System is manufactured by Cook Incorporated.

What is the FDA product code for Rhapsody H-30 Holmium Laser System?

The FDA product code for Rhapsody H-30 Holmium Laser System is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.