510(k) K250774
- Device
- SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
- Applicant
- PAJUNK GmbH Medizintechnologie
- 510(k) number
- K250774
- Product code
- BSP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-25
- Date received
- 2025-03-14
- Regulation
- 868.5150
- Classification name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christian Quass
- Address
- Karl-Hall-Str. 1 Pajunkstr. 1 Geisingen DE 78187 78187
FDA Registration Numbers#
- 1000563940
- 3015173212
- 3006271008
- 9681709
- 3006425876
- 9611481
- 3003898360
- 1056553
- 1211566
- 2027619
- 3010966701
- 1832216
- 3009518015
- 3002807314
- 1316297
- 3006345872
- 1625425
- 3009265194
- 3011237770
- 1420054
- 9617604
- 9680591
- 3006260740
- 3013162291
- 2032112
- 1047843
- 2032521
- 2011171
- 2433012
- 3019729537
- 1319639
- 3040339315
- 1018233
- 1054241
- 3007441619
- 1928237
- 1828424
- 1423507
- 1018470
- 9680425
- 3000268902
- 3013188547
- 3017567825
- 9610825
- 3005580113
- 3010055973
- 1422634
- 3013764800
- 1055236
- 3004111573
- 3010321647
- 3009039068
- 1644312
- 2243072
- 1643817
- 3003152976
- 1820334
- 1047429
- 9680222
- 3015859709
- 3030626857
- 1417485
- 3020983482
- 1061124
- 3043226252
- 3005012805
- 3004365956
- 1000587249
- 3015967359
- 3038356900
- 3035642068
- 3009888344
- 3029901632
- 9610993
- 1643059
- 1043214
- 2320762
- 3004076349
- 3001845648
Source Documents#
Other 510(k) Records For Product Code BSP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243690 | SonoMSK | PAJUNK GmbH Medizintechnologie | 2025-07-01 |
| K243682 | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie | 2025-06-27 |
| K243525 | SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie | 2025-03-24 |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | 2024-11-22 |
| K241954 | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | 2024-09-11 |
| K240253 | Reach Needle | Aerin Medical, Inc. | 2024-03-21 |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | 2022-07-29 |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton, Dickinson and Company | 2022-07-01 |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | Becton, Dickinson and Company | 2021-12-22 |
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | Myco Medical Supplies, Inc. | 2021-09-29 |
| K212328 | DiscCath Needle Set | Disccath, LLC | 2021-09-26 |
| K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | Becton, Dickinson and Company | 2020-09-29 |
| K192914 | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | 2020-05-27 |
| K191290 | Ancora Nerve Block Catheter Set | Ancora Medical Technology | 2020-02-06 |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | Teleflex Medical | 2019-08-21 |