Cephalotomy Scissors
FDA 510(k) K890388 · Kinetic Medical Products
510(k) numberK890388
Submission
- Device name
- Cephalotomy Scissors
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 23, 1989
- Decision date
- February 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNB – Instrument, Destructive, Fetal, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4500
- Specialty
- Obstetrics/Gynecology
More from Kinetic Medical Products
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
| K890384 | Uterine CuretteHCY · Traditional | 02/13/1989SE |
Questions and answers
When was Cephalotomy Scissors cleared by the FDA?
Cephalotomy Scissors (K890388) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 21 days after the submission was received.
What is the product code of K890388?
The FDA product code is KNB – Instrument, Destructive, Fetal, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.4500.