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K Number
K980536
Device Name
EPIDURAL NEEDLE
Manufacturer
MANAN MEDICAL PRODUCTS, INC.
Date Cleared
1998-07-31

(170 days)

Product Code
BSP
Regulation Number
868.5150
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.

Device Description

Epidural Needle (Touhy, Hustead, Crawford, Weiss)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an "Epidural Needle." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.

Therefore, I cannot provide the requested table and study details based on the provided text. The document is solely a regulatory clearance letter.

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).