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FDA 510(k)

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

K-Number: K183636 · 2019-01-22

ApplicantBoston Scientific Corporation
Decision Date2019-01-22
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-01-22 under approval number K183636. 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 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller?

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by Boston Scientific Corporation. The 510(k) number is K183636.

When was SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller approved by the FDA?

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller received FDA 510(k) clearance on 2019-01-22, under approval number K183636.

What company makes SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller?

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller is manufactured by Boston Scientific Corporation.

What is the FDA product code for SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller?

The FDA product code for SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller is FBN.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT06938412 Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation RECRUITING NCT07595289 DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT Platform NOT_YET_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING

Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

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Related Devices (Code: FBN)

K161147EndoCure Model EUR078AEndocure Technologies, Inc. K181439SpyGlass DS and DS II Direct Visualization SystemBoston 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. K222261Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric 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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