Deflecting Cytology Brush
FDA 510(k) K822490 · Van-Tec, Inc.
510(k) numberK822490
Submission
- Device name
- Deflecting Cytology Brush
- Applicant
- Van-Tec, Inc.
Mchenry, IL, US - Received
- August 18, 1982
- Decision date
- September 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEE – Brush, Biopsy, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K854003 | Sterile Soft Tissue Biopsy NeedleGEE · Traditional | Co-Medical, Inc. | 10/18/1985SE |
| K841008 | Biopsy Punch, VariousGEE · Traditional | Premier Dental Products Co. | 06/08/1984SE |
| K820259 | Sterile Cytology BrushesGEE · Traditional | American Endoscopy, Inc. | 03/05/1982SE |
| K812694 | Whisk-RGEE · Traditional | Medi-Spec | 10/26/1981SE |
| K801304 | Camloc Syringe Biopsy KitGEE · Traditional | Johannah Medical Services, Inc. | 06/17/1980SE |
| K792316 | Trotex II Screw Needle Biopsy Instr. SetGEE · Traditional | Ursus Konsult AB | 12/18/1979SE |
More from Ursus Konsult AB
| 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 Deflecting Cytology Brush cleared by the FDA?
Deflecting Cytology Brush (K822490) received a 510(k) decision of Substantially Equivalent on September 14, 1982, 27 days after the submission was received.
What is the product code of K822490?
The FDA product code is GEE – Brush, Biopsy, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.