PAPILLOTOME CUTTING SNARE— 510(k) K781353

Substantially Equivalent

Cameron-Miller, Inc.

FDA 510(k) clearance K781353 for PAPILLOTOME CUTTING SNARE, Substantially Equivalent on 1978-10-10. Applicant: Cameron-Miller, Inc..

Clearance details

Applicant
Cameron-Miller, Inc.
Product code
Code KNS
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

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 →

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