POWER-DRIVE, WISAP MODEL #7688PD/7688PD1— 510(k) K982515

Substantially Equivalent

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

FDA 510(k) clearance K982515 for POWER-DRIVE, WISAP MODEL #7688PD/7688PD1, Substantially Equivalent on 1999-01-19. Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh.

Clearance details

Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1998-07-20
Decision date: 1999-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sauerlach, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.