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FDA 510(k)

SpyGlass DS and DS II Direct Visualization System

K-Number: K181439 · 2018-08-23

ApplicantBoston Scientific Corporation
Decision Date2018-08-23
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpyGlass DS and DS II Direct Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K181439. 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 SpyGlass DS and DS II Direct Visualization System?

SpyGlass DS and DS II Direct Visualization System is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Boston Scientific Corporation. The 510(k) number is K181439.

When did SpyGlass DS and DS II Direct Visualization System receive FDA 510(k) clearance?

SpyGlass DS and DS II Direct Visualization System received FDA 510(k) clearance on 2018-08-23, under 510(k) number K181439.

Who is the listed applicant for SpyGlass DS and DS II Direct Visualization System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpyGlass DS and DS II Direct Visualization System?

The FDA product code for SpyGlass DS and DS II Direct Visualization System is FBN.

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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.

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.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.

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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