IPGTFL-02
K-Number: K251100 · 2025-09-19
ApplicantIpg Medical Corporation
Decision Date2025-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
IPGTFL-02 is a medical device manufactured by Ipg Medical Corporation. It received FDA 510(k) clearance on 2025-09-19 under approval number K251100. 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 IPGTFL-02?
IPGTFL-02 is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Ipg Medical Corporation. The 510(k) number is K251100.
When was IPGTFL-02 approved by the FDA?
IPGTFL-02 received FDA 510(k) clearance on 2025-09-19, under approval number K251100.
What company makes IPGTFL-02?
IPGTFL-02 is manufactured by Ipg Medical Corporation.
What is the FDA product code for IPGTFL-02?
The FDA product code for IPGTFL-02 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.