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FDA 510(k)

Disposable Dual Action Tissue Closure Device

K-Number: K233772 · 2024-03-19

ApplicantMirco-Tech (Nanjing) Co., Ltd.
Decision Date2024-03-19
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Dual Action Tissue Closure Device is a medical device manufactured by Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under approval number K233772. 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 Disposable Dual Action Tissue Closure Device?

Disposable Dual Action Tissue Closure Device is a medical device that received FDA 510(k) clearance on 2024-03-19. It is manufactured by Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K233772.

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

Disposable Dual Action Tissue Closure Device received FDA 510(k) clearance on 2024-03-19, under approval number K233772.

What company makes Disposable Dual Action Tissue Closure Device?

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

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

The FDA product code for Disposable 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)

Other Devices by Mirco-Tech (Nanjing) Co., Ltd.

K253832Dilation Balloon Catheter K254153Single-use Video Scope; PB Digital Controller K253139Disposable Distal Cap

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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