HBAClass II
Neurosurgical Paddie
21 CFR 882.4700 / Neurology
HBA is the FDA product code for Neurosurgical Paddie, a class II device type, regulated under 21 CFR 882.4700. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 78 recalls.
Classification record
- Product code
- HBA
- Device name
- Neurosurgical Paddie
- Regulation
- 21 CFR 882.4700
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 24
- Ingested recalls
- 78
Clearances, product code HBA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1988 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 2 |
| 1995 | 1 |
| 1997 | 3 |
| 2000 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2020 | 1 |
Applicants with the most clearances
Product code HBA| Applicant | Clearances |
|---|---|
| American Silk Sutures, Inc. | 4 |
| Ultracell Medical Technologies, Inc. | 3 |
| Aesculap Inc | 2 |
| American Surgical Company, LLC | 2 |
| American Surgical Sponges | 1 |
| Cerenovus, Inc. | 1 |
| Harod Enterprises, Inc. | 1 |
| I M, Inc. | 1 |
| Instranetics, Inc. | 1 |
| Integra LifeSciences Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Allmed Industrial Limited
- Allmed Medical Products Co., Ltd.
- American Surgical Company, LLC
- Carwild Corp.
- CBR Enterprise Limited
- DeRoyal Industries, Inc.
- Euroband Bioline Ltd.
- Integra LifeSciences Corporation
- Integra LifeSciences Production Corporation
- Isomedix Operations Inc
- LYNX Medical NJ
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.