510(k) K093236— ETHICON ENDO-SURGERYOPTICAL DILATOR

Substantially Equivalent

Ethicon Endo-Surgery, Inc.

Clearance details

Applicant: Ethicon Endo-Surgery, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-15
Decision date: 2009-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.