Cleared Special

K202478 - Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares

K202478 is an FDA 510(k) clearance for Captivator Single-Use Polypectomy Snares, manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Special 510(k) pathway after a 41-day FDA review.

K202478 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
41d
Days
Class 2
Risk

K202478 is an FDA 510(k) clearance for the Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn.... Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on October 8, 2020 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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.

FDA 510(k) Submission Details - K202478

510(k) Number K202478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2020
Decision Date October 08, 2020
Days to Decision 41 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
90d faster than avg
Panel avg: 131d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

FDI Device Classification - Class 2, Special Controls

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - FDI Snare, Flexible

All 62
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K202478.
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K202478 · Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
Download PDF FDA Summary Boston Scientific Cor…