DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Trokamed GmbH
Product code
Code HET
Device class
Class 2
Regulation
21 CFR 884.1720
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Amsterdam, Nh, NL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HET

product code HET
Malfunction
10,504
Total
10,504

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K091010

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091010.

Data sourced from openFDA. This site is unofficial and independent of the FDA.