510(k) K003710— DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905

Substantially Equivalent

Smith & Nephew, Inc.

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2000-12-01
Decision date: 2001-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.