← Back to catalogue

Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD FACS Pattern)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972700

by Exmoor Plastics , Ltd.

Identifiers

510(k) Number
K972700 FDA 510(k)
FDA Product Code
KHJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.3620 FDA 510(k)
Regulation Number
874.3620 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Exmoor Attic and Mastoid Antrum Middle Ear Implant is a synthetic polyamide device designed for use following tympanomastoid surgery. It is placed within the attic and mastoid antrum to improve aeration, with the narrow end positioned under the malleus head.

This device is a Class 2 medical device that has received FDA 510(k) clearance under K972700. It is manufactured by Exmoor Plastics, Ltd. and is regulated under the Ear, Nose, and Throat medical specialty.

Frequently asked questions

What is the primary clinical purpose of this implant?

This device is designed for use following tympanomastoid surgery. It is placed within the attic and mastoid antrum to improve aeration, with the narrow end positioned under the malleus head.

What material is used to manufacture this middle ear implant?

The implant is constructed from a synthetic polyamide material, which is a polymer used in ear, nose, and throat medical applications.

What is the regulatory status of this device?

This is a Class 2 medical device that has received FDA 510(k) clearance under K972700. It is regulated under the Ear, Nose, and Throat medical specialty.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell Md ..., Exmoor Attic And Mastoid Antrum Middle Ear Implant (emmett Campbell Md ..., Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell Md ..., fda.innolitics.com, Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell Md ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Exmoor Plastics , Ltd.

Sources (1)

  • FDA 510(k) K972700 24 fields · synced Oct 6, 2026