FDA 510(k)

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

K-Number: K232568 · 2024-03-21

Decision Date2024-03-21

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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

When was IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories approved by the FDA?

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

What company makes IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is manufactured by Ipg Medical Corporation.

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.

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Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39964125 Potential health benefits of lactoferrin and derived peptides - how to qualify as a medical device? Critical reviews in microbiology (2025)

Other Devices by Ipg Medical Corporation

K251100IPGTFL-02

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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.