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FDA 510(k)

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories

K-Number: K232568 · 2024-03-21

ApplicantIpg Medical Corporation
Decision Date2024-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ipg Medical Corporation. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K232568. 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 IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Ipg Medical Corporation. The 510(k) number is K232568.

When did IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories receive FDA 510(k) clearance?

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories received FDA 510(k) clearance on 2024-03-21, under 510(k) number K232568.

Who is the listed applicant for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

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

What is the FDA product code for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

The FDA product code for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is GEX. This falls under the Gastroenterology category.

Other records listing Ipg Medical 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.

K251100IPGTFL-02K233344Regenalase Laser System

Related Devices (Code: GEX)

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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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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