MANAN SPINAL NEEDLES

• K Number: K983620
• Device Name: MANAN SPINAL NEEDLES
• Manufacturer: MANAN MEDICAL PRODUCTS, INC.
• Date Cleared: 1999-01-08 ( 85 days)
• Product Code: BSP
• Regulation Number: 868.5150
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

For the spinal administration of anesthetic agents to elicit regional anesthesia.

Device Description

Spinal Needle

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a spinal needle. It does not contain any information about acceptance criteria, device performance studies, or the use of AI/algorithms.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study designs. The document is strictly a regulatory clearance letter acknowledging substantial equivalence to a predicate device.

Regulation Number and Section

§ 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).