Van-Tec Bladder Evacuator
FDA 510(k) K880099 · Van-Tec, Inc.
510(k) numberK880099
Submission
- Device name
- Van-Tec Bladder Evacuator
- Applicant
- Van-Tec, Inc.
Spencer, IN, US - Received
- January 12, 1988
- Decision date
- March 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQT – Evacuator, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4370
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KQT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | Electro Medical Systems SA | 12/16/1996SE |
| K921451 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K921088 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K910728 | Cleanflow SystemKQT · Traditional | Mitron Technologies, Inc. | 04/01/1991SE |
| K874493 | Bella - Vac IrrigatorKQT · Traditional | Bel-Can Industries | 02/05/1988SE |
| K860266 | Ellik EvacuatorKQT · Traditional | R. J. Ltd., Ind. | 03/05/1986SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | American Hospital Supply Corp. | 05/25/1983SE |
| K811779 | Ross-Emerson Pump, Model 55-RKQT · Traditional | J. H. Emerson Co. | 07/13/1981SE |
| K810739 | Suction Wound Drainage DeviceKQT · Traditional | The Urology Group | 06/26/1981SE |
| K801782 | General Purpose Irrigating/Aspir Syr.KQT · Traditional | The Healthcare Group Laboratories, Inc. | 08/13/1980SE |
More from The Healthcare Group Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K870557 | Van-Tec Pumping SystemKOD · Traditional | 03/30/1987SE |
Questions and answers
When was Van-Tec Bladder Evacuator cleared by the FDA?
Van-Tec Bladder Evacuator (K880099) received a 510(k) decision of Substantially Equivalent on March 2, 1988, 50 days after the submission was received.
What is the product code of K880099?
The FDA product code is KQT – Evacuator, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.4370.