FMJ · Manometer, Spinal-Fluid
General Hospital · 21 CFR 880.2500 · Class 2
Overview
| Product Code | FMJ |
|---|---|
| Device Name | Manometer, Spinal-Fluid |
| Regulation | 21 CFR 880.2500 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | Jul 25, 2017 | SESE |
| K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | Busse Hospital Disposables, Inc. | Aug 28, 2003 | SESE |
| K970287 | LUMBAR PUNCTURE KIT | B.Braun Medical, Inc. | Apr 7, 1997 | SESE |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | Smiths Industries Medical Systems, Inc. | Oct 18, 1996 | SESE |
| K910089 | MEGA LUMBAR PUNCTURE KIT | Megadyne Medical Products, Inc. | Jun 20, 1991 | SESK |
| K882405 | HYPODERMIC NEEDLE SHEATH HOLDER | Ansr Ent., Inc. | Jun 29, 1988 | SESE |
Top Applicants
- Ansr Ent., Inc. — 1 clearance
- B.Braun Medical, Inc. — 1 clearance
- Busse Hospital Disposables, Inc. — 1 clearance
- Megadyne Medical Products, Inc. — 1 clearance
- PAJUNK GmbH Medizintechnologie — 1 clearance
