Hall Irrigation System
FDA 510(k) K852143 · Hall Surgical, Division of Zimmer, Inc.
510(k) numberK852143
Submission
- Device name
- Hall Irrigation System
- Applicant
- Hall Surgical, Division of Zimmer, Inc.
`Anta Barbara, CA, US - Received
- May 16, 1985
- Decision date
- June 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K131659 | Moerae Vein Preparation KitGBX · Traditional | Moerae Matrix, Inc. | 03/03/2014SE |
| K082725 | Graftguard Pressure Controlling SyringeGBX · Traditional | Maquet Cardiovascular, LLC | 12/17/2008SE |
| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942660 | Hall Microchoice Electric Powered SystemHWE · Traditional | 09/07/1994SE |
| K864734 | Hall Oral Implant SystemDZE · Traditional | 02/10/1987SE |
| K864929 | Hall (R) Micro E Powered Surgical Instrument SystHWE · Traditional | 01/28/1987SE |
| K864163 | Hall Dunbar Drill Guide SystemHRX · Traditional | 11/20/1986SE |
| K862778 | Hall Cannlula SystemHRX · Traditional | 09/08/1986SE |
| K862474 | Hall Sternum SawDWH · Traditional | 07/17/1986SE |
| K862529 | Hall Sterile BurHTT · Traditional | 07/15/1986SE |
Questions and answers
When was Hall Irrigation System cleared by the FDA?
Hall Irrigation System (K852143) received a 510(k) decision of Substantially Equivalent on June 26, 1985, 41 days after the submission was received.
What is the product code of K852143?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.