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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 a medical device manufactured by Bison Medical Co, Ltd.. It received FDA 510(k) clearance on 2016-04-22 under approval 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. It is manufactured by Bison Medical Co, Ltd.. The 510(k) number is K160227.

When was ACCENTO / HWA Dual/Single laser approved by the FDA?

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

What company makes ACCENTO / HWA Dual/Single laser?

ACCENTO / HWA Dual/Single laser is manufactured by Bison Medical Co, Ltd..

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.

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Other Devices by Bison Medical Co, Ltd.

K161670Lucid Q-PTP / HWA 55

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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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