NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20— 510(k) K994223

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K994223 for NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20, Substantially Equivalent on 2000-06-05. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code FGA
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-15
Decision date: 2000-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGA

product code FGA

Death: 7
Total: 7

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.