STORZ RANEY SCALP CLIP, MODEL 1-20-004-05

• K Number: K033660
• Device Name: STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
• Manufacturer: RUDOLF STORZ GMBH
• Date Cleared: 2004-01-07 ( 47 days)
• Product Code: HBO
• Regulation Number: 882.4150
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The STORZ Raney Scalp Clip is a device designed to stop bleeding during surgery on the scalp.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Scalp Clips." The provided document is a letter from the FDA to the manufacturer, Rudolf Storz GmbH, stating that their device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) summary or a more detailed technical submission, which is not included in the provided pages.

Therefore, I cannot answer the request with the provided input.

Regulation Number and Section

§ 882.4150 Scalp clip.

(a)
Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.(b)
Classification. Class II (performance standards).