ULTRACELL NEURO SPONGES

• K Number: K973083
• Device Name: ULTRACELL NEURO SPONGES
• Manufacturer: ULTRACELL MEDICAL TECHNOLOGIES, INC.
• Date Cleared: 1997-12-09 ( 113 days)
• Product Code: HBA
• Regulation Number: 882.4700
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Neuro sponges are used during surgery to protect the brain tissue from dryness, trauma, absorb fluids and act as a filter to aspirate.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "Ultracell Neuro Sponges." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is solely a clearance letter approving the device for marketing based on substantial equivalence.

Therefore, I cannot provide the requested information in the format specified because the source material does not include it. The document confirms market clearance but does not detail the technical performance criteria or the studies conducted to establish that performance.

Regulation Number and Section

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).