DeviceClearance

AXIOS Stent and Electrocautery-Enhanced Delivery System (6 models)— 510(k) K233318

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K233318 for AXIOS Stent and Electrocautery-Enhanced Delivery System (6 models), Substantially Equivalent on 2023-10-27. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Device name as filed
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); 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)
Applicant
Boston Scientific Corporation
Product code
Code KNS
Device class
Class 2
Regulation
21 CFR 876.4300
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Marlboro, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KNS

product code KNS
Death
44
Injury
2,361
Malfunction
4,771
Total
7,176

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K233318

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233318.

Data sourced from openFDA. This site is unofficial and independent of the FDA.