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FDA 510(k)

Lucid Q-PTP / HWA 55

K-Number: K161670 · 2016-11-02

Decision Date2016-11-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lucid Q-PTP / HWA 55 is the device name listed in this FDA 510(k) record. The listed applicant is Bison Medical Co, Ltd.. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K161670. 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 Lucid Q-PTP / HWA 55?

Lucid Q-PTP / HWA 55 is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Bison Medical Co, Ltd.. The 510(k) number is K161670.

When did Lucid Q-PTP / HWA 55 receive FDA 510(k) clearance?

Lucid Q-PTP / HWA 55 received FDA 510(k) clearance on 2016-11-02, under 510(k) number K161670.

Who is the listed applicant for Lucid Q-PTP / HWA 55?

The FDA 510(k) record lists Bison Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucid Q-PTP / HWA 55?

The FDA product code for Lucid Q-PTP / HWA 55 is GEX. This falls under the Gastroenterology category.

Other records listing Bison Medical Co, Ltd. 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.

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.

Official Source

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