Splint, Nasal
FDA product code EPP · Class I (low risk) · 21 CFR 874.5800 · Ear, Nose, Throat
15510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942158 | Aquaplast Nasal Splints, Precut Silver Splint Patterns and Splint KitsEPP · Traditional | Wfr/Aquaplast Corp. | 07/29/1994SE |
| K942724 | External Nasal SplintEPP · Traditional | Micromed Development Corp. | 07/08/1994SE |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal SplintEPP · Traditional | Microbio-Medics, Inc. | 12/08/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | Hood Laboratories | 03/17/1989SE |
| K882244 | Richards Thermoplastic Dorsal Nasal SplintEPP · Traditional | Richards Medical Co., Inc. | 06/23/1988SE |
| K872905 | American Nasal SpongeEPP · Traditional | American Silk Sutures, Inc. | 09/04/1987SE |
| K864933 | 'Exmoor' Shah & Mackay Nasal SplintsEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864932 | 'Exmoor' Cawood Nasal SplintsEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864930 | 'Exmoor' Atkins Nasal SplintEPP · Traditional | Exmoor Plastics , Ltd. | 03/04/1987SE |
| K864934 | 'Exmoor' Shah Silicone DiscsEPP · Traditional | Exmoor Plastics , Ltd. | 01/28/1987SE |
| K863382 | Cannon Nasal SplintEPP · Traditional | Treace Medical, Inc. | 10/07/1986SE |
| K862496 | Microtek Intranasal SplintEPP · Traditional | Microtek Medical, Inc. | 07/14/1986SE |
| K810738 | Goode Magnetic Nasal SplintEPP · Traditional | Xomed, Inc. | 03/31/1981SE |
| K791681 | The Denver SplintEPP · Traditional | Xomed, Inc. | 10/22/1979SE |
| K791053 | The Denver SplintEPP · Traditional | Ronald D. Shippert, M.D. | 08/16/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1700-2011 | Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF…Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad… | Medtronic Xomed, Inc. | 02/21/2011Terminated |
| Z-1699-2011 | An external nasal splint is a rigid or partially rigid device intended for the use…Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad… | Medtronic Xomed, Inc. | 02/21/2011Terminated |