Product code KNE— Obstetrics/Gynecology
EPICATH
- Classification name
- Set, Anesthesia, Obstetric
- Device class
- Class 2
- Regulation
- 21 CFR 884.5100
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code KNE
FDA has cleared devices under product code KNE between 1986 and 1988, filed by 2 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
- 1988
- 1986
Top applicants under product code KNE
Recent clearances under product code KNE
Data sourced from openFDA. This site is unofficial and independent of the FDA.