JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810— 510(k) K030053

Substantially Equivalent

Jomed AG

FDA 510(k) clearance K030053 for JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810, Substantially Equivalent on 2003-03-31. Applicant: Jomed AG.

Clearance details

Applicant: Jomed AG
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2002-12-23
Decision date: 2003-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.