DeviceClearance

Product code LKF— Obstetrics/Gynecology

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

Classification name
Cannula, Manipulator/Injector, Uterine
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
87
First cleared
Most recent

Market context for product code LKF

FDA has cleared 87 devices under product code LKF between 1978 and 2025, filed by 47 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LKF

Adverse events under product code LKF

product code LKF
Malfunction
643
Other
2
Total
645

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 →

Recent clearances under product code LKF

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