H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005— 510(k) K013972

Substantially Equivalent

Ackard Laboratories

FDA 510(k) clearance K013972 for H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005, Substantially Equivalent on 2001-12-17. Applicant: Ackard Laboratories.

Clearance details

Applicant: Ackard Laboratories
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2001-12-03
Decision date: 2001-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Cranford, NJ, US

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Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.