FDA 510(k)

Single-use Video Pancreaticobiliary Scope, PB Digital Controller

K-Number: K221784 · 2023-02-16

Decision Date2023-02-16

Product CodeFBN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under approval number K221784. 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 Pancreaticobiliary Scope, PB Digital Controller?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K221784.

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

Single-use Video Pancreaticobiliary Scope, PB Digital Controller received FDA 510(k) clearance on 2023-02-16, under approval number K221784.

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

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

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

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

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION NCT07136506 Gait Analysis Parameter and Upper Limb Evaluation in Control Participants RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING

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 Micro-Tech (Nanjing) Co., Ltd.

K162466LuminScan (TM) Imaging System K160625Disposable Hot Biopsy Forceps K152802Grasping Forceps K172309Endoscopic Ultrasound Aspiration Needle K162226Reliant Multistage Dilatation Balloon Catheter K161463SureClip(TM) Repositionable Hemostasis Clip

View all 37 devices →

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.