Cleared Special

K181439 - SpyGlass DS and DS II Direct Visualizat...

K181439 is the FDA 510(k) clearance for SpyGlass DS and DS II Direct Visualizat... by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FBN) cleared through the Special 510(k) pathway after a 83-day FDA review.

K181439 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
83d
Days
Class 2
Risk

K181439 is an FDA 510(k) clearance for the SpyGlass DS and DS II Direct Visualization System. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on August 23, 2018 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K181439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date August 23, 2018
Days to Decision 83 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FBN Choledochoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Bile Ducts. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FBN Choledochoscope And Accessories, Flexible/rigid

All 34
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K181439.
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784 · Micro-Tech (Nanjing) Co., Ltd. · Feb 2023
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
K200483 · Boston Scientific Corporation · May 2020
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
K183636 · Boston Scientific Corporation · Jan 2019
SpyGlass DS Direct Visualization System
K142922 · Boston Scientific Corporation · Jan 2015
CHF-Y0005
K113120 · Olympus Medical Systems Corp. · Sep 2012
OLYMPUS CHF TYPE Y0003
K093507 · Olympus Medical Systems Corporation · Mar 2010