Stoppers
FDA 510(k) K760384 · B. Braun Instruments
510(k) numberK760384
Submission
- Device name
- Stoppers
- Applicant
- B. Braun Instruments
Mchenry, IL, US - Received
- August 5, 1976
- Decision date
- November 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022306 | Aart Silicone TubingKGZ · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 10/10/2002SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | Byron Medical | 02/10/1998SE |
| K973183 | Wound Drainage HolderKGZ · Traditional | R & D Medical Products, Inc. | 01/23/1998SE |
| K955433 | Duralastic Silicone TubingKGZ · Traditional | Allied Biomedical Corp. | 01/26/1996SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | Navarre Biomedical , Ltd. | 07/08/1994SE |
| K896087 | Palestrant Irrigation and Drainage SetKGZ · Traditional | North American Instrument Corp. | 11/03/1989SE |
| K895041 | Optical Catheter(Tm) Introducer SetsKGZ · Traditional | Medical Dynamics, Inc. | 10/16/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
| K873009 | Concept Switching StickKGZ · Traditional | Concept, Inc. | 08/17/1987SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
More from Health Care Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K760392 | SyringesFMF · Traditional | 11/02/1976SE |
| K760391 | Catheter, Vein (Braunula)JCY · Traditional | 11/02/1976SE |
| K760390 | Catheter, Vein (Braunula T)JCY · Traditional | 11/02/1976SE |
| K760389 | Cannula, IVFGY · Traditional | 11/02/1976SE |
| K760388 | Catheter, Vein (Venofix)DQO · Traditional | 11/02/1976SE |
| K760387 | Catheter, Cava (Cavafix)DQO · Traditional | 11/02/1976SE |
| K760386 | Central Veinous Pressure SetsDQO · Traditional | 11/02/1976SE |
| K760385 | Extension SetsKGZ · Traditional | 11/02/1976SE |
| K760383 | StopcocksKGZ · Traditional | 11/02/1976SE |
| K760382 | ConnectorsGCD · Traditional | 11/02/1976SE |
Questions and answers
When was Stoppers cleared by the FDA?
Stoppers (K760384) received a 510(k) decision of Substantially Equivalent on November 2, 1976, 89 days after the submission was received.
What is the product code of K760384?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.