GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R— 510(k) K061050

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K061050 for GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R, Substantially Equivalent on 2006-07-14. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2006-04-17
Decision date: 2006-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, 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.