LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED— 510(k) K923260

Substantially Equivalent

Imtec Corp.

FDA 510(k) clearance K923260 for LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED, Substantially Equivalent on 1994-06-09. Applicant: Imtec Corp..

Clearance details

Applicant: Imtec Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1992-07-02
Decision date: 1994-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Palm Baeach, FL, US

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.