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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 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 2026-04-03 under 510(k) 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. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K254153.

When did Single-use Video Scope; PB Digital Controller receive FDA 510(k) clearance?

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

Who is the listed applicant for Single-use Video Scope; PB Digital Controller?

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 Single-use Video Scope; PB Digital Controller?

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

Related Clinical Trials

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.

NCT07557147Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-MonitorNOT_YET_RECRUITING

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 CatheterK253139Disposable Distal CapK233772Disposable 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.

K253139Disposable Distal CapMirco-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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