FDA 510(k)

ASAHI Gladius Mongo18 PV ES

K-Number: K213868 · 2022-09-06

Decision Date2022-09-06

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Gladius Mongo18 PV ES is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2022-09-06 under 510(k) number K213868. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI Gladius Mongo18 PV ES?

ASAHI Gladius Mongo18 PV ES is a medical device that received FDA 510(k) clearance on 2022-09-06. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K213868.

When did ASAHI Gladius Mongo18 PV ES receive FDA 510(k) clearance?

ASAHI Gladius Mongo18 PV ES received FDA 510(k) clearance on 2022-09-06, under 510(k) number K213868.

Who is the listed applicant for ASAHI Gladius Mongo18 PV ES?

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

What is the FDA product code for ASAHI Gladius Mongo18 PV ES?

The FDA product code for ASAHI Gladius Mongo18 PV ES is DQX.

Other records listing Asahi Intecc Co., Ltd. as applicant

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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.