TROKAMED MORCELLATOR— 510(k) K091010

Substantially Equivalent

Trokamed GmbH

FDA 510(k) clearance K091010 for TROKAMED MORCELLATOR, Substantially Equivalent on 2011-03-01. Applicant: Trokamed GmbH.

Clearance details

Applicant: Trokamed GmbH
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2009-04-09
Decision date: 2011-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, Nh, NL

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.