BSPClass II
Needle, Conduction, Anesthetic (W/Wo Introducer)
21 CFR 868.5150 / Anesthesiology
BSP is the FDA product code for Needle, Conduction, Anesthetic (W/Wo Introducer), a class II device type, regulated under 21 CFR 868.5150. As of , FDA records hold 152 510(k) clearances under this code, the most recent dated , and 17 recalls.
Classification record
- Product code
- BSP
- Device name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Regulation
- 21 CFR 868.5150
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 152
- Ingested recalls
- 17
Clearances, product code BSP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 4 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 1 |
| 1989 | 6 |
| 1990 | 1 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 7 |
| 1994 | 1 |
| 1995 | 16 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 4 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 4 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 8 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 6 |
| 2017 | 4 |
| 2018 | 8 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 2 |
| 2024 | 3 |
| 2025 | 4 |
Applicants with the most clearances
Product code BSP| Applicant | Clearances |
|---|---|
| Pajunk GmbH Medizintechnologie | 21 |
| Epimed International, Inc. | 6 |
| B.Braun Medical, Inc. | 5 |
| Holgrath Medical Technologies, Inc. | 5 |
| R. J. Doyle, Inc. | 5 |
| Abbott Medical | 5 |
| Becton Dickinson & Co | 4 |
| Burron Medical Products, Inc. | 4 |
| Argon Medical Devices, Inc | 4 |
| Sherwood Medical Co. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 7051395 Canada Inc dba Hta Direct Sourcing
- Abbott Medical
- Advance Medical Designs Inc
- Aerin Medical, Inc.
- Argon Medical Devices, Inc
- Arrow Internacional de Chihuahua S.A. de C.V.
- Arrow International C.R. A.S.
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- AVENT S. de R.L. de C.V.
- Avid Medical, Inc. a Medical Action Ind. Company 305
- B Braun Medical Inc
- B. Braun Aesculap Japan Co., Ltd.
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