Aart Silicone Tubing
FDA 510(k) K022306 · Aesthetic and Reconstructive Technologies, Inc.
510(k) numberK022306
Submission
- Device name
- Aart Silicone Tubing
- Applicant
- Aesthetic and Reconstructive Technologies, Inc.
Paso Robles, CA, US - Received
- July 16, 2002
- Decision date
- October 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K864115 | Tubegripper, Drainage Catheter & Accessory for SuKGZ · Traditional | Cathaid, Inc. | 11/07/1986SE |
More from Cathaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023678 | Dimisil Scar GelMDA · Traditional | 01/23/2003SE |
| K022511 | Aart Calf ImplantMIB · Traditional | 08/26/2002SE |
| K022223 | Aart Silicone SheetingMIB · Traditional | 08/08/2002SE |
| K021839 | Aart Gluteal ImplantMIB · Traditional | 07/16/2002SE |
| K021820 | Aart Silicone Carving BlockMIB · Traditional | 07/16/2002SE |
| K021337 | Aart Pectoralis ImplantMIC · Traditional | 07/03/2002SE |
| K021419 | Aart Malar ImplantLZK · Traditional | 07/02/2002SE |
| K021418 | Aart Nasal ImplantFZE · Traditional | 07/02/2002SE |
| K021417 | Aart Chin ImplantFWP · Traditional | 07/02/2002SE |
Questions and answers
When was Aart Silicone Tubing cleared by the FDA?
Aart Silicone Tubing (K022306) received a 510(k) decision of Substantially Equivalent on October 10, 2002, 86 days after the submission was received.
What is the product code of K022306?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.