Product code FMJ
- Device name
- Manometer, Spinal-Fluid
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2500
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | 2017-07-25 |
| K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | Busse Hospital Disposables, Inc. | 2003-08-28 |
| K970287 | LUMBAR PUNCTURE KIT | B.Braun Medical, Inc. | 1997-04-07 |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | Smiths Industries Medical Systems, Inc. | 1996-10-18 |
| K910089 | MEGA LUMBAR PUNCTURE KIT | Megadyne Medical Products, Inc. | 1991-06-20 |
| K882405 | HYPODERMIC NEEDLE SHEATH HOLDER | Ansr Ent., Inc. | 1988-06-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048223131374 | Spinal Manometer NRFit | Pajunk GmbH Medizintechnologie | 2025-11-19 |
| 04048223131046 | Manometer Extension Tube - 20cm | Pajunk GmbH Medizintechnologie | 2025-06-17 |
| 04048223132425 | Manometer Extension Tube - 20cm | Pajunk GmbH Medizintechnologie | 2025-06-17 |
| 04048223069578 | Spinal Manometer | Pajunk GmbH Medizintechnologie | 2025-01-30 |
| 04048223048986 | Spinal Manometer | Pajunk GmbH Medizintechnologie | 2025-01-30 |
| 00849233008779 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2022-11-10 |
| 00849233008762 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2022-11-04 |
| 00849233008809 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2022-11-04 |
| 10849233008769 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2022-11-04 |
| 10849233008806 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2022-11-04 |
| 04048223049204 | MANOMETER | Pajunk GmbH Medizintechnologie | 2021-04-02 |
| 04048223049860 | MANOMETER | Pajunk GmbH Medizintechnologie | 2021-04-02 |
| 00849233004917 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2020-09-10 |
| 10849233004914 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2020-09-10 |
| 14048223022563 | Manometer Extension Tube - 20cm | Pajunk GmbH Medizintechnologie | 2020-07-15 |
| 04048223022566 | Manometer Extension Tube - 20cm | Pajunk GmbH Medizintechnologie | 2020-07-15 |
| 04048223029770 | Spinal Manometer NRFit | Pajunk GmbH Medizintechnologie | 2020-07-06 |
| 14048223029777 | Spinal Manometer NRFit | Pajunk GmbH Medizintechnologie | 2020-07-06 |
| 00849233010369 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2020-04-09 |
| 00849233003064 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2020-04-09 |
| 00849233000247 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2020-04-09 |
| 20884521020402 | Curity | Cardinal Health, Inc. | 2016-09-24 |
| 20884521020341 | Curity | Cardinal Health, Inc. | 2016-09-24 |
| 20884521020365 | Curity | Cardinal Health, Inc. | 2016-09-24 |
| 10884521020405 | Curity | Cardinal Health, Inc. | 2016-09-24 |
| 10884521020344 | Curity | Cardinal Health, Inc. | 2016-09-24 |
| 00849233013742 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2016-09-02 |
| 00849233013216 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2016-09-01 |
| 50885632114845 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-20 |
| 10885632114847 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-20 |