MILTEX LAPAROSCOPIC INSTRUMENTS— 510(k) K043013

Substantially Equivalent

Miltex, Inc.

FDA 510(k) clearance K043013 for MILTEX LAPAROSCOPIC INSTRUMENTS, Substantially Equivalent on 2005-03-04. Applicant: Miltex, Inc..

Clearance details

Applicant: Miltex, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2004-11-02
Decision date: 2005-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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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.