Micro-Sp Lumbar Puncture (Spinal) Needle
510(k) K901810
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901810 | Date30 May 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BSP
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Micro-Sp Lumbar Puncture (Spinal) Needle is a medical device classified as a conduction, anesthetic needle with or without an introducer. It is designed for use in lumbar puncture procedures to facilitate the collection of cerebrospinal fluid for diagnostic analysis.
This device is regulated under the anesthesiology specialty and received FDA 510(k) clearance under reference number K901810. It is intended for clinical use by medical professionals in accordance with standard lumbar puncture protocols.
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Questions
AI-generated answers, 6 Oct 2026
What is the primary clinical use of the Micro-Sp Lumbar Puncture Needle?
The Micro-Sp Lumbar Puncture (Spinal) Needle is designed for use in lumbar puncture procedures to facilitate the collection of cerebrospinal fluid for diagnostic analysis.
Who is authorized to use this spinal needle?
This device is intended for clinical use by medical professionals and must be used in accordance with standard lumbar puncture protocols to ensure patient safety and procedural efficacy.
Does the needle come with an introducer?
The device is classified as a conduction, anesthetic needle and may be supplied with or without an introducer to assist in the lumbar puncture procedure.
What is the regulatory status of this device?
The Micro-Sp Lumbar Puncture (Spinal) Needle received FDA 510(k) clearance under reference number K901810, which confirms its regulatory status for the specified clinical indications.