TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES— 510(k) K942389

Substantially Equivalent

Hogan & Hartson

FDA 510(k) clearance K942389 for TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES, Substantially Equivalent on 1996-02-16. Applicant: Hogan & Hartson.

Clearance details

Applicant: Hogan & Hartson
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-05-18
Decision date: 1996-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.