BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS— 510(k) K945995

Substantially Equivalent

Ximed/Prosure/Injectx

FDA 510(k) clearance K945995 for BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS, Substantially Equivalent on 1995-01-31. Applicant: Ximed/Prosure/Injectx.

Clearance details

Applicant: Ximed/Prosure/Injectx
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1994-10-06
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.