Cleared Traditional

K200483 - SpyGlass Discover Digital Catheter

K200483 is the FDA 510(k) clearance for SpyGlass Discover Digital Catheter by Boston Scientific Corporation. It is a Class 2 General & Plastic Surgery device (product code FBN) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K200483 · Boston Scientific Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
84d
Days
Class 2
Risk

K200483 is an FDA 510(k) clearance for the SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller. 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 May 21, 2020 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K200483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2020
Decision Date May 21, 2020
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery 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 K200483.
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R
K223741 · Zhuhai Pusen Medical Technology Co., Ltd. · Jun 2023
Flexible Video-Choledochoscope System
K222261 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Apr 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784 · Micro-Tech (Nanjing) Co., Ltd. · Feb 2023
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 and DS II Direct Visualization System
K181439 · Boston Scientific Corporation · Aug 2018
SpyGlass DS Direct Visualization System
K142922 · Boston Scientific Corporation · Jan 2015