MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)— 510(k) K122498

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K122498 for MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK), Substantially Equivalent on 2012-09-10. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2012-08-16
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Malborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.