Product code EPP
- Device name
- Splint, Nasal
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5800
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Wfr/Aquaplast Corp. | 1994-07-29 |
| K942724 | EXTERNAL NASAL SPLINT | Micromed Development Corp. | 1994-07-08 |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Microbio-Medics, Inc. | 1989-12-08 |
| K890599 | HOOD NASAL SPLINT | Hood Laboratories | 1989-03-17 |
| K882244 | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | Richards Medical Co., Inc. | 1988-06-23 |
| K872905 | AMERICAN NASAL SPONGE | American Silk Sutures, Inc. | 1987-09-04 |
| K864930 | 'EXMOOR' ATKINS NASAL SPLINT | Exmoor Plastics , Ltd. | 1987-03-04 |
| K864932 | 'EXMOOR' CAWOOD NASAL SPLINTS | Exmoor Plastics , Ltd. | 1987-03-04 |
| K864933 | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | Exmoor Plastics , Ltd. | 1987-03-04 |
| K864934 | 'EXMOOR' SHAH SILICONE DISCS | Exmoor Plastics , Ltd. | 1987-01-28 |
| K863382 | CANNON NASAL SPLINT | Treace Medical, Inc. | 1986-10-07 |
| K862496 | MICROTEK INTRANASAL SPLINT | Microtek Medical, Inc. | 1986-07-14 |
| K810738 | GOODE MAGNETIC NASAL SPLINT | Xomed, Inc. | 1981-03-31 |
| K791681 | THE DENVER SPLINT | Xomed, Inc. | 1979-10-22 |
| K791053 | THE DENVER SPLINT | Ronald D. Shippert, M.D. | 1979-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08906039312508 | OSSEOUSExternal Thermoplastic Splint | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039311501 | OSSEOUSExternal Thermoplastic Splint | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039310504 | OSSEOUSExternal Thermoplastic Splint | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039310573 | OSSEOUS Silicone Sheets | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039312492 | OSSEOUS External Aluminium Splints | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039312485 | OSSEOUS Internal Nasal Bi-valve Splint - Standard | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039312478 | OSSEOUS Internal Nasal Pre-Cut Splint | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039311495 | OSSEOUS External Aluminium Splints | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039311488 | OSSEOUS Internal Nasal Bi-valve Splint - Thick | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039311471 | OSSEOUS Internal Nasal Airways Splint - Large | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310733 | OSSEOUS Silicone Block | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310726 | OSSEOUS Silicone Block | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310719 | OSSEOUS Silicone Block | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310603 | OSSEOUS Silicone Sheets | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310597 | OSSEOUS Silicone Sheets | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310580 | OSSEOUS Silicone Sheets | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310566 | OSSEOUS Silicone Sheets | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310481 | OSSEOUS Internal Nasal Bi-valve Splint - Standard(Silicone) | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310474 | OSSEOUS Internal Nasal Airways Splint - Standard | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08906039310467 | OSSEOUS Silicone Sheets | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904461000109 | OSSEOUS Fluoroplastic Sheet | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904461000093 | OSSEOUS Fluoroplastic Sheet | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904461000086 | OSSEOUS Fluoroplastic Sheet | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904428721382 | OSSEOUS Silicone Sheeting Clear Folios | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904428721375 | OSSEOUS Silicone Sheeting Blue Folios | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904428721368 | OSSEOUS Silicone Sheeting Clear Folios | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904428721351 | OSSEOUS Silicone Sheeting Blue Folios | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904428721344 | OSSEOUS Silicone Sheeting Clear Folios | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 00821925034020 | Gyrus ACMI | Gyrus ACMI, LLC | 2018-09-13 |
| 00821925034037 | Gyrus ACMI | Gyrus ACMI, LLC | 2018-09-13 |