Microsurgery Razor Blade Holder
FDA 510(k) K890214 · Kinetic Medical Products
510(k) numberK890214
Submission
- Device name
- Microsurgery Razor Blade Holder
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 18, 1989
- Decision date
- January 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EMF – Knife, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080133 | Mountable Endoscopic BladeEMF · Traditional | A.M. Surgical, Inc. | 03/13/2008SE |
| K982142 | Mountable Endoscopic KnifeEMF · Traditional | A.M. Surgical, Inc. | 12/30/1998SE |
| K890217 | Microsurgical KnivesEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890215 | Microsurgical ScarifierEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | Van-Tec, Inc. | 02/29/1988SE |
| K863752 | Valtrac (Bar) Remover DeviceEMF · Traditional | Davis & Geck, Inc. | 10/24/1986SE |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | Surgipath Medical Industries, Inc. | 09/30/1986SE |
| K861947 | Surgical KnifeEMF · Traditional | Sharpoint, Inc. | 06/06/1986SE |
| K854891 | KnifeEMF · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K851784 | 27-210 Plaster Knife (Reiner)EMF · Traditional | Artiberia | 06/20/1985SE |
More from Artiberia
| 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 |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
Questions and answers
When was Microsurgery Razor Blade Holder cleared by the FDA?
Microsurgery Razor Blade Holder (K890214) received a 510(k) decision of Substantially Equivalent on January 27, 1989, 9 days after the submission was received.
What is the product code of K890214?
The FDA product code is EMF – Knife, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.