LAPARO-TENSER— 510(k) K970712

Substantially Equivalent

L & T S.N.C. DI E. Lucini & C.

FDA 510(k) clearance K970712 for LAPARO-TENSER, Substantially Equivalent on 1998-07-21. Applicant: L & T S.N.C. DI E. Lucini & C..

Clearance details

Applicant: L & T S.N.C. DI E. Lucini & C.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1997-02-26
Decision date: 1998-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, IT

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.