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FDA 510(k)

BTL-754FF

K-Number: K252561 · 2026-02-18

ApplicantBTL Industries, Inc.
Decision Date2026-02-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-754FF is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K252561. 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-754FF?

BTL-754FF is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is BTL Industries, Inc.. The 510(k) number is K252561.

When did BTL-754FF receive FDA 510(k) clearance?

BTL-754FF received FDA 510(k) clearance on 2026-02-18, under 510(k) number K252561.

Who is the listed applicant for BTL-754FF?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTL-754FF?

The FDA product code for BTL-754FF is GEX. This falls under the Gastroenterology category.

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Other records listing BTL Industries, Inc. 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.

K252963BTL-899TTK253750BTL-785NEHK250309BTL-199K243290BTL-785MJK241516BTL-398K241270BTL-754

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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

View on FDA Database →

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

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