SEMM SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)— 510(k) K960640

Name: FDA 510(k) clearance K960640
Creator: U.S. Food and Drug Administration
Published: 1997-02-14

Substantially Equivalent

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

FDA 510(k) clearance K960640 for S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION), Substantially Equivalent on 1997-02-14. Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. Device class: 2.

Clearance details

Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1996-02-12
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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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.