CABOT MEDICAL UTERINE RESECTOSCOPE— 510(k) K924631

Substantially Equivalent

Cabot Medical Corp.

FDA 510(k) clearance K924631 for CABOT MEDICAL UTERINE RESECTOSCOPE, Substantially Equivalent on 1994-05-16. Applicant: Cabot Medical Corp..

Clearance details

Applicant: Cabot Medical Corp.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1992-09-14
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, 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.