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FDA 510(k)

Dual Action Tissue Closure Device

K-Number: K250229 · 2025-09-08

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2025-09-08
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dual Action Tissue Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K250229. 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 Dual Action Tissue Closure Device?

Dual Action Tissue Closure Device is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K250229.

When did Dual Action Tissue Closure Device receive FDA 510(k) clearance?

Dual Action Tissue Closure Device received FDA 510(k) clearance on 2025-09-08, under 510(k) number K250229.

Who is the listed applicant for Dual Action Tissue Closure Device?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual Action Tissue Closure Device?

The FDA product code for Dual Action Tissue Closure Device is PKL.

Other records listing Micro-Tech (Nanjing) 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.

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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.

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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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