BTL-754
K-Number: K241270 · 2025-01-30
ApplicantBTL Industries, Inc.
Decision Date2025-01-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BTL-754 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2025-01-30 under approval number K241270. 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 BTL-754?
BTL-754 is a medical device that received FDA 510(k) clearance on 2025-01-30. It is manufactured by BTL Industries, Inc.. The 510(k) number is K241270.
When was BTL-754 approved by the FDA?
BTL-754 received FDA 510(k) clearance on 2025-01-30, under approval number K241270.
What company makes BTL-754?
BTL-754 is manufactured by BTL Industries, Inc..
What is the FDA product code for BTL-754?
The FDA product code for BTL-754 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.