SODEM PERFORATOR DRIVE— 510(k) K993851

Substantially Equivalent

Sodemsystems

FDA 510(k) clearance K993851 for SODEM PERFORATOR DRIVE, Substantially Equivalent on 1999-12-27. Applicant: Sodemsystems.

Clearance details

Applicant: Sodemsystems
Product code: Code HBB
Advisory panel: Neurology
Date received: 1999-11-12
Decision date: 1999-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, Switzerland, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.