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FDA 510(k)

PICO-K

K-Number: K253342 · 2025-12-24

ApplicantSpeclipse, Inc.
Decision Date2025-12-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICO-K is the device name listed in this FDA 510(k) record. The listed applicant is Speclipse, Inc.. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253342. 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 PICO-K?

PICO-K is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Speclipse, Inc.. The 510(k) number is K253342.

When did PICO-K receive FDA 510(k) clearance?

PICO-K received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253342.

Who is the listed applicant for PICO-K?

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

What is the FDA product code for PICO-K?

The FDA product code for PICO-K is GEX. This falls under the Gastroenterology category.

Other records listing Speclipse, 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.

K261214PICO SHINING (PICO-K; PICOFY)K253344BELLUS-Q

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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