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FDA 510(k)

Disposable Distal Cap

K-Number: K253139 · 2026-03-19

ApplicantMirco-Tech (Nanjing) Co., Ltd.
Decision Date2026-03-19
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Distal Cap is the device name listed in this FDA 510(k) record. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K253139. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Distal Cap?

Disposable Distal Cap is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K253139.

When did Disposable Distal Cap receive FDA 510(k) clearance?

Disposable Distal Cap received FDA 510(k) clearance on 2026-03-19, under 510(k) number K253139.

Who is the listed applicant for Disposable Distal Cap?

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

What is the FDA product code for Disposable Distal Cap?

The FDA product code for Disposable Distal Cap is FBN.

Other records listing Mirco-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.

K260262Injection NeedleK253832Dilation Balloon CatheterK254153Single-use Video Scope; PB Digital ControllerK233772Disposable Dual Action Tissue Closure Device

Related Devices (Code: FBN)

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.

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLCK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel CapsCenterPoint Systems, LLC

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.

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