DeviceClearance

AUTOTOME RX MODEL # 4515, 4516— 510(k) K013153

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K013153 for AUTOTOME RX MODEL # 4515, 4516, Substantially Equivalent on 2001-10-19. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant
Boston Scientific Corp
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
Natick,, 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 K013153

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 K013153.

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