Lutz Needle
FDA 510(k) K013892 · Ballard Medical Products
510(k) numberK013892
Submission
- Device name
- Lutz Needle
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- November 23, 2001
- Decision date
- July 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K030721 | Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special | 03/31/2003SE |
| K022398 | Reusable Bronchial Biopsy ForcepsBWH · Traditional | 10/11/2002SE |
| K000495 | Ballard Medical Products Epidural and Spinal NeedlesBSP · Traditional | 03/28/2000SE |
| K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement KitKNT · Special | 10/20/1999SE |
| K990376 | Ballard Medical Products Faciletome Bow String PapillotomeKNS · Traditional | 05/03/1999SE |
| K982894 | Mic-Key Glow Profile Gastrostomy Replacement KitKNT · Special | 09/11/1998SE |
| K974630 | 72 Hour Use Trach Care with MicrobanCAH · Traditional | 03/11/1998SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | 02/11/1997SE |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | 07/05/1995SE |
| K923487 | Bal CathKTR · Traditional | 07/30/1993SESK |
Questions and answers
When was Lutz Needle cleared by the FDA?
Lutz Needle (K013892) received a 510(k) decision of Substantially Equivalent on July 11, 2002, 230 days after the submission was received.
What is the product code of K013892?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.