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

The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.

Device Description

Partial Ossicular Replacement Prosthesis (PORP)

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a medical device: "Partial Ossicular Replacement Prosthesis (PORP)". This type of document declares substantial equivalence to a predicate device, allowing it to be marketed. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo performance studies with acceptance criteria as might be seen for novel technologies or PMA applications.

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K Number

K964798

Device Name

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

Manufacturer

ANTHONY D. PRESCOTT

Date Cleared

1997-01-02

(34 days)

Product Code