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FDA 510(k)

Hemoclip (511 series, 543 series)

K-Number: K254069 · 2026-08-10

Decision Date2026-08-10
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Hemoclip (511 series, 543 series) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K254069. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemoclip (511 series, 543 series)?

Hemoclip (511 series, 543 series) is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K254069.

When did Hemoclip (511 series, 543 series) receive FDA 510(k) clearance?

Hemoclip (511 series, 543 series) received FDA 510(k) clearance on 2026-08-10, under 510(k) number K254069.

Who is the listed applicant for Hemoclip (511 series, 543 series)?

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

What is the FDA product code for Hemoclip (511 series, 543 series)?

The FDA product code for Hemoclip (511 series, 543 series) is PKL.

Other records listing Hangzhou AGS MedTech 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.

View all 19 devices →

Related Devices (Code: PKL)

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