Van-Tec Fascial Dilator
FDA 510(k) K820865 · Van-Tec, Inc.
510(k) numberK820865
Submission
- Device name
- Van-Tec Fascial Dilator
- Applicant
- Van-Tec, Inc.
Walker, MI, US - Received
- March 29, 1982
- Decision date
- May 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCC – Dilator, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981061 | Intravascular Retrieval DeviceGCC · Traditional | Med Institute, Inc. | 05/26/1998SE |
| K922354 | Byrd Telescoping Stainless Steel Dilat Sheath SetGCC · Traditional | Med Institute, Inc. | 07/30/1992SE |
| K902502 | Byrd Stainless Steel DilatorGCC · Traditional | Medical Engineering and Development Institute | 08/07/1990SE |
| K893480 | Byrd Extractor SetGCC · Traditional | Medical Engineering and Development Institute | 06/23/1989SE |
More from Medical Engineering and Development Institute
| 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 |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | 02/29/1988SE |
| 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 |
Questions and answers
When was Van-Tec Fascial Dilator cleared by the FDA?
Van-Tec Fascial Dilator (K820865) received a 510(k) decision of Substantially Equivalent on May 5, 1982, 37 days after the submission was received.
What is the product code of K820865?
The FDA product code is GCC – Dilator, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.