HYDROFERA FEMORAL WICK

• K Number: K974316
• Device Name: HYDROFERA FEMORAL WICK
• Manufacturer: HYDROFERA, LLC.
• Date Cleared: 1998-02-13 ( 88 days)
• Product Code: EFQ
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The absorbent dressing is indicated for use in hip arthroplasty.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Femoral Wick." It does not contain any information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than being cleared based on a specific performance study against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information from this document.

Regulation Number and Section

N/A