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FDA 510(k)

Ligation Device

K-Number: K172985 · 2018-06-14

Decision Date2018-06-14
Product CodeFHN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ligation Device is the device name listed in this FDA 510(k) record. The listed applicant is Leo Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172985. The device is classified under product code FHN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ligation Device?

Ligation Device is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Leo Medical Co., Ltd.. The 510(k) number is K172985.

When did Ligation Device receive FDA 510(k) clearance?

Ligation Device received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172985.

Who is the listed applicant for Ligation Device?

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

What is the FDA product code for Ligation Device?

The FDA product code for Ligation Device is FHN.

Other records listing Leo 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: FHN)

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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