Cleared Special

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm) (K233318) - FDA 510(k) Clearance

Also marketed or referenced as:
AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm) AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm) AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm) AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm) AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233318 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
28d
Days
Class 2
Risk

K233318 is an FDA 510(k) clearance for the AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm). Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on October 27, 2023 after a review of 28 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.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K233318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date October 27, 2023
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 187
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