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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 a medical device manufactured by Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-19 under approval 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. It is manufactured by Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K253139.

When was Disposable Distal Cap approved by the FDA?

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

What company makes Disposable Distal Cap?

Disposable Distal Cap is manufactured by Mirco-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Disposable Distal Cap?

The FDA product code for Disposable Distal Cap is FBN.

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

K233772Disposable Dual Action Tissue Closure Device K253832Dilation Balloon Catheter K254153Single-use Video Scope; PB Digital Controller

Related Devices (Code: FBN)

K161147EndoCure Model EUR078AEndocure Technologies, Inc. K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerBoston Scientific Corporation K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation K231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)Shanghai AnQing Medical Instrument Co., Ltd. K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd.

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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