Duralastic Silicone Tubing
FDA 510(k) K955433 · Allied Biomedical Corp.
510(k) numberK955433
Submission
- Device name
- Duralastic Silicone Tubing
- Applicant
- Allied Biomedical Corp.
Paso Robles, CA, US - Received
- November 28, 1995
- Decision date
- January 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K982051 | Kelocate SheetingMDA · Traditional | 08/05/1998SE |
| K971481 | Duralastic Anatomical Nasal ImplantsFZE · Traditional | 07/18/1997SE |
| K971479 | Duralastic Anatomical Malar ImplantsLZK · Traditional | 07/18/1997SE |
| K971478 | Duralastic Anatomical Chin ImplantsFWP · Traditional | 07/18/1997SE |
| K971480 | Duralastic I and Duralastic IIMIB · Traditional | 05/28/1997SE |
| K955370 | Duralastic IIMIB · Traditional | 02/08/1996SE |
| K955368 | Duralastic IMIB · Traditional | 02/08/1996SE |
| K954413 | KelocoteMDA · Traditional | 11/29/1995SE |
Questions and answers
When was Duralastic Silicone Tubing cleared by the FDA?
Duralastic Silicone Tubing (K955433) received a 510(k) decision of Substantially Equivalent on January 26, 1996, 59 days after the submission was received.
What is the product code of K955433?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.