KZHClass II
Introducer, Syringe Needle
21 CFR 880.6920 / General Hospital
KZH is the FDA product code for Introducer, Syringe Needle, a class II device type, regulated under 21 CFR 880.6920. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- KZH
- Device name
- Introducer, Syringe Needle
- Regulation
- 21 CFR 880.6920
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 47
- Ingested recalls
- 10
Clearances, product code KZH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 1 |
| 1990 | 1 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code KZH| Applicant | Clearances |
|---|---|
| Owen Mumford USA, Inc. | 4 |
| Medtronic, Inc. | 3 |
| Scandinavian Health Ltd. | 3 |
| Hdc Corp. | 2 |
| Owen Mumford Limited | 2 |
| Pavel Jordan & Associates, Inc. | 2 |
| Shl Medical, USA | 2 |
| American Medical Innovations, Inc. | 1 |
| Androsystems SRL | 1 |
| Animas Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.