FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Proxiderm is intended to be utilized prior to a surgical procedure to remove a defect or prior to implantation of a prosthesis to provide additional skin for coverage of the defect or prosthesis.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for a device called "Proxiderm." The letter states that the device is substantially equivalent to legally marketed predicate devices. However, the provided document does not contain any information about acceptance criteria, device performance, studies, sample sizes, expert qualifications, or ground truth.

Therefore, I cannot provide the requested table and study details. This document is a regulatory clearance, not a technical report or scientific study summary.

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K Number

K970439

Device Name

PROXIDERM (D-460,D 90 460,D 180,460, PS 460)

Manufacturer

PROGRESSIVE SURGICAL PRODUCTS, INC.

Date Cleared

1997-04-16

(70 days)

Product Code