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FDA 510(k)

ACCENTO / HWA Dual/Single laser

K-Number: K160227 · 2016-04-22

ApplicantBison Medical Co, Ltd.
Decision Date2016-04-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCENTO / HWA Dual/Single laser 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 2016-04-22 under 510(k) number K160227. 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 ACCENTO / HWA Dual/Single laser?

ACCENTO / HWA Dual/Single laser is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Bison Medical Co, Ltd.. The 510(k) number is K160227.

When did ACCENTO / HWA Dual/Single laser receive FDA 510(k) clearance?

ACCENTO / HWA Dual/Single laser received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160227.

Who is the listed applicant for ACCENTO / HWA Dual/Single laser?

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 ACCENTO / HWA Dual/Single laser?

The FDA product code for ACCENTO / HWA Dual/Single laser 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.

K161670Lucid Q-PTP / HWA 55

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

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

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