ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE— 510(k) K981256

Substantially Equivalent

Ximed/Prosure/Injectx

FDA 510(k) clearance K981256 for ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE, Substantially Equivalent on 1998-05-12. Applicant: Ximed/Prosure/Injectx.

Clearance details

Applicant: Ximed/Prosure/Injectx
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1998-04-02
Decision date: 1998-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.