Exmoor Teflon Loop Replacement Prosthesis
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K981045 FDA 510(k)
- FDA Product Code
- ETB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3450 FDA 510(k)
- Regulation Number
- 874.3450 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Exmoor Teflon Loop Replacement Prosthesis is a Partial Ossicular Replacement Prosthesis, designed to reconstruct defects in the ossicular chain of the middle ear, specifically involving the stapes and incus. This device is intended for use in otologic surgery to restore conductive hearing by bridging gaps or replacing damaged ossicles, ensuring proper sound transmission from the tympanic membrane to the inner ear.
This prosthesis is supplied sterile and intended for single-use, with regulatory clearance under FDA 510(k) (K981045) as a Class II device (regulation number 874.3450). It is manufactured by Exmoor Plastics, Ltd. and distributed in sterile packaging for surgical use in otolaryngology settings. The device’s design adheres to Ear, Nose, and Throat (ENT) surgical standards, with no noted MRI safety restrictions or reusable specifications.
Frequently asked questions
What is the Exmoor Teflon Loop Replacement Prosthesis used for in surgical settings?
The Exmoor Teflon Loop Replacement Prosthesis is designed to reconstruct defects in the ossicular chain of the middle ear, particularly involving the stapes and incus. It helps restore conductive hearing by bridging gaps or replacing damaged ossicles, ensuring proper sound transmission from the tympanic membrane to the inner ear. This makes it specifically useful in otologic (ear) surgeries.
Is the Exmoor Teflon Loop Replacement Prosthesis intended for single-use or can it be reused?
The device is explicitly labeled for single-use only. It is supplied sterile in packaging designed for surgical use, which aligns with its intended one-time application in otolaryngology procedures.
What sizes or models of the Exmoor Teflon Loop Replacement Prosthesis are available?
The provided data does not specify individual sizes or model variants, but the device is categorized under the FDA’s product code ETB for Partial Ossicular Replacement Prostheses. For exact sizing or model details, refer to the manufacturer’s technical documentation or contact Exmoor Plastics, Ltd.
How should the Exmoor Teflon Loop Replacement Prosthesis be stored before use?
Since the device is supplied sterile in sealed packaging, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for the specific packaging to maintain sterility until use.
Does the Exmoor Teflon Loop Replacement Prosthesis have any restrictions for use in MRI environments?
The device’s data does not mention any MRI safety restrictions, but this does not imply MRI compatibility. For MRI-related concerns, consult the manufacturer’s instructions or verify compatibility with your MRI machine’s specifications, as Teflon-based materials may still pose risks in high-field MRI environments.
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 TEFLON LOOP REPLACEMENT PROSTHESIS (K981045) — FDA 510(k ..., EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS 510(k)… - FDA.report, K981045 - Prosthesis, Partial Ossicular Replacement FDA 510 (k ..., Exmoor Plastics , Ltd. FDA 510 (k) Products (1981-2010)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981045 | Class II | Active |
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Manufacturer
- Manufacturer
- Exmoor Plastics , Ltd.
Sources (1)
- FDA 510(k) K981045 24 fields · synced Sep 19, 2026