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FDA 510(k)

Hemoclip

K-Number: K252270 · 2026-04-08

Decision Date2026-04-08
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Hemoclip 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 2026-04-08 under 510(k) number K252270. 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?

Hemoclip is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K252270.

When did Hemoclip receive FDA 510(k) clearance?

Hemoclip received FDA 510(k) clearance on 2026-04-08, under 510(k) number K252270.

Who is the listed applicant for Hemoclip?

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?

The FDA product code for Hemoclip 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

View on FDA Database →

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