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FDA 510(k)

Single-use Video Scope; PB Digital Controller

K-Number: K254153 · 2026-04-03

ApplicantMirco-Tech (Nanjing) Co., Ltd.
Decision Date2026-04-03
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Video Scope; PB Digital Controller is a medical device manufactured by Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-03 under approval number K254153. 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 Single-use Video Scope; PB Digital Controller?

Single-use Video Scope; PB Digital Controller is a medical device that received FDA 510(k) clearance on 2026-04-03. It is manufactured by Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K254153.

When was Single-use Video Scope; PB Digital Controller approved by the FDA?

Single-use Video Scope; PB Digital Controller received FDA 510(k) clearance on 2026-04-03, under approval number K254153.

What company makes Single-use Video Scope; PB Digital Controller?

Single-use Video Scope; PB Digital Controller is manufactured by Mirco-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Single-use Video Scope; PB Digital Controller?

The FDA product code for Single-use Video Scope; PB Digital Controller is FBN.

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Related PubMed Literature

PMID: 40206521 Embedding Internal Accountability Into Health Care Institutions for Safe, Effective, and Ethical Implementation of Artificial Intelligence Into Medical Practice: A Mayo Clinic Case Study. Mayo Clinic proceedings. Digital health (2024)

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

K233772Disposable Dual Action Tissue Closure Device K253832Dilation Balloon Catheter K253139Disposable Distal Cap

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 →

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