Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2500](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2500) → FMJ — Manometer, Spinal-Fluid

# FMJ · Manometer, Spinal-Fluid

_General Hospital · 21 CFR 880.2500 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ

## Overview

- **Product Code:** FMJ
- **Device Name:** Manometer, Spinal-Fluid
- **Regulation:** [21 CFR 880.2500](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2500)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K170305.md) | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | Jul 25, 2017 | SESE |
| [K032432](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K032432.md) | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | Busse Hospital Disposables, Inc. | Aug 28, 2003 | SESE |
| [K970287](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K970287.md) | LUMBAR PUNCTURE KIT | B.Braun Medical, Inc. | Apr 7, 1997 | SESE |
| [K963570](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K963570.md) | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | Smiths Industries Medical Systems, Inc. | Oct 18, 1996 | SESE |
| [K910089](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K910089.md) | MEGA LUMBAR PUNCTURE KIT | Megadyne Medical Products, Inc. | Jun 20, 1991 | SESK |
| [K882405](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ/K882405.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FMJ)

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