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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 a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-08 under approval 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. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K250229.

When was Dual Action Tissue Closure Device approved by the FDA?

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

What company makes Dual Action Tissue Closure Device?

Dual Action Tissue Closure Device is manufactured by Micro-Tech (Nanjing) Co., Ltd..

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

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

Related Clinical Trials

NCT05492721 Comparing Tissue Adhesives in Port Site Closure COMPLETED NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT05313555 The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin TERMINATED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT02030691 Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress COMPLETED

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

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Related Devices (Code: PKL)

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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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