20GA X 7-1/2 Threading Bullet Point Needle
FDA 510(k) K894881 · R. J. Doyle, Inc.
510(k) numberK894881
Submission
- Device name
- 20GA X 7-1/2 Threading Bullet Point Needle
- Applicant
- R. J. Doyle, Inc.
Spirit Lake, ID, US - Received
- August 1, 1989
- Decision date
- November 30, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
Other 510(k)s with product code BSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243690 | SonoMSKBSP · Traditional | PAJUNK GmbH Medizintechnologie | 07/01/2025SE |
| K243682 | SonoPlex STIM; SonoPlex IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/27/2025SE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/25/2025SE |
| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | PAJUNK GmbH Medizintechnologie | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 09/11/2024SE |
| K240253 | Reach NeedleBSP · Traditional | Aerin Medical, Inc. | 03/21/2024SE |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal NeedleBSP · Traditional | Global Medikit Limited | 07/29/2022SE |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional | Becton, Dickinson and Company | 07/01/2022SE |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional | Becton, Dickinson and Company | 12/22/2021SE |
More from Becton, Dickinson and Company
| 510(k) | Device | Decision |
|---|---|---|
| K894882 | Infiltration Pump SyringeBSP · Traditional | 11/30/1989SE |
| K894880 | 16GA X 14 Fourteen Long Long Bullet Point NeedlBSP · Traditional | 11/30/1989SE |
| K894879 | 16GA X 10 Middle Size Bullet Point NeedleBSP · Traditional | 11/30/1989SE |
| K894878 | 16GA X 6 Bullet Point Needle, Flex Stainless SteeBSP · Traditional | 11/30/1989SE |
| K894875 | 20GA X 7-1/2 Threading Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K894874 | 14 Inch Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K894873 | 16 Ga X 10 Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K894872 | 16 Ga X 6 Bullet Point NeedleGAA · Traditional | 09/22/1989SE |
| K872200 | Hamacher Bullet Point Ophthalmic NeedleHMX · Traditional | 06/25/1987SE |
Questions and answers
When was 20GA X 7-1/2 Threading Bullet Point Needle cleared by the FDA?
20GA X 7-1/2 Threading Bullet Point Needle (K894881) received a 510(k) decision of Substantially Equivalent on November 30, 1989, 121 days after the submission was received.
What is the product code of K894881?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.