Novo Vivo Suction Catheter Vessel W/Mucose Trap
FDA 510(k) K880376 · Genesis Industries, Inc.
510(k) numberK880376
Submission
- Device name
- Novo Vivo Suction Catheter Vessel W/Mucose Trap
- Applicant
- Genesis Industries, Inc.
Spring Valley, WI, US - Received
- January 27, 1988
- Decision date
- February 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBS – Catheter, Ventricular, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912645 | Atriums PDR Thoracic CatheterGBS · Traditional | Atrium Medical Corp. | 09/13/1991SE |
| K883887 | Axiom Atraum Wound DrainsGBS · Traditional | Axiom, Inc. | 02/17/1989SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | Sheridan Catheter Corp. | 05/18/1988SE |
| K880895 | Uresil Wound Drain TrocarGBS · Traditional | Uresil Corp. | 03/14/1988SE |
| K873377 | Closed Chest Drainage Set W/SuturesGBS · Traditional | Gish Biomedical, Inc. | 10/28/1987SE |
| K872460 | AN3000 Mahoney DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/23/1987SE |
| K872459 | AN3100 Mulholland DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K872457 | AN3500 Worth DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K870015 | Hci All Purpose Drain/Catheter SetGBS · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
| K863560 | Uresil STD Flat/Round & Flat/Round Split. Sili/DraGBS · Traditional | Uresil Corp. | 09/29/1986SE |
More from Uresil Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K994361 | Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp Micro Six…MQK · Traditional | 02/18/2000SE |
| K962828 | Evert-ItHGY · Traditional | 02/10/1997SE |
| K880377 | Novo Vivo Model #17140 and #17135GAA · Traditional | 04/04/1988SE |
| K833290 | C & B 40 Pentro C & B40EIS · Traditional | 01/03/1984SE |
| K833287 | Satin Cast EconocastEIS · Traditional | 01/03/1984SE |
| K833289 | C & B 61 Pentron C & B61EIS · Traditional | 12/29/1983SE |
| K833278 | C & B 45EIS · Traditional | 12/29/1983SE |
| K833280 | Supra Ap Choice 83EIS · Traditional | 12/26/1983SE |
| K833285 | RX IV Pentron IVEIS · Traditional | 12/22/1983SE |
| K833288 | C & B57 Pentron C & B57EIS · Traditional | 12/20/1983SE |
Questions and answers
When was Novo Vivo Suction Catheter Vessel W/Mucose Trap cleared by the FDA?
Novo Vivo Suction Catheter Vessel W/Mucose Trap (K880376) received a 510(k) decision of Substantially Equivalent on February 16, 1988, 20 days after the submission was received.
What is the product code of K880376?
The FDA product code is GBS – Catheter, Ventricular, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.