Van-Tec Endopyelotomy Knife
FDA 510(k) K880094 · Van-Tec, Inc.
510(k) numberK880094
Submission
- Device name
- Van-Tec Endopyelotomy Knife
- Applicant
- Van-Tec, Inc.
Spencer, IN, US - Received
- January 12, 1988
- Decision date
- February 29, 1988
- 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 |
| K890214 | Microsurgery Razor Blade HolderEMF · Traditional | Kinetic Medical Products | 01/27/1989SE |
| 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 |
|---|---|---|
| K880099 | Van-Tec Bladder EvacuatorKQT · Traditional | 03/02/1988SE |
| K880098 | Van-Tec Auto Biopsy NeedleKNW · Traditional | 03/02/1988SE |
| K880096 | Van-Tec Aspiration Biopsy System W/Collection CupKNW · Traditional | 03/02/1988SE |
| K880095 | Berger Prostate Culture Cytology BrushFDX · Traditional | 03/02/1988SE |
| K874112 | Van-Tec Double Occlusion Balloon CatheterKOD · Traditional | 02/11/1988SE |
| K871779 | Helical Stone Basket (Disposable)FFL · Traditional | 06/17/1987SE |
| K871777 | Van-Tec Reusable Helical Stone BasketFFL · Traditional | 06/17/1987SE |
| K870696 | Van-Tec Segura Stone Basket W/Protective SheathFFL · Traditional | 03/30/1987SE |
| K870679 | Van-Tec Modular Flexible CystourethroscopeFBO · Traditional | 03/30/1987SE |
| K870557 | Van-Tec Pumping SystemKOD · Traditional | 03/30/1987SE |
Questions and answers
When was Van-Tec Endopyelotomy Knife cleared by the FDA?
Van-Tec Endopyelotomy Knife (K880094) received a 510(k) decision of Substantially Equivalent on February 29, 1988, 48 days after the submission was received.
What is the product code of K880094?
The FDA product code is EMF – Knife, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.