Splint, Nasal
The nasal splint is a supportive device placed inside or outside the nose following rhinoplasty or septoplasty to maintain the corrected nasal structure during the healing process. It is classified as FDA Class 1, the lowest regulatory risk category, subject only to general controls and no premarket submission requirement. The product code is EPP, regulated under 21 CFR 874.5800 in the Ear, Nose, Throat specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EPP
- Device Class
- FDA class 1
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Jul 29, 1994 | Substantially Equivalent | Wfr/Aquaplast Corp. |
| K942724 | EXTERNAL NASAL SPLINT | Jul 08, 1994 | Substantially Equivalent | Micromed Development Corp. |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Dec 08, 1989 | Substantially Equivalent | Microbio-Medics, Inc. |
| K890599 | HOOD NASAL SPLINT | Mar 17, 1989 | Substantially Equivalent | Hood Laboratories |
| K882244 | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | Jun 23, 1988 | Substantially Equivalent | Richards Medical Co., Inc. |
| K872905 | AMERICAN NASAL SPONGE | Sep 04, 1987 | Substantially Equivalent | American Silk Sutures, Inc. |
| K864933 | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | Mar 04, 1987 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K864932 | 'EXMOOR' CAWOOD NASAL SPLINTS | Mar 04, 1987 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K864930 | 'EXMOOR' ATKINS NASAL SPLINT | Mar 04, 1987 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K864934 | 'EXMOOR' SHAH SILICONE DISCS | Jan 28, 1987 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K863382 | CANNON NASAL SPLINT | Oct 07, 1986 | Substantially Equivalent | Treace Medical, Inc. |
| K862496 | MICROTEK INTRANASAL SPLINT | Jul 14, 1986 | Substantially Equivalent | Microtek Medical, Inc. |
| K810738 | GOODE MAGNETIC NASAL SPLINT | Mar 31, 1981 | Substantially Equivalent | Xomed, Inc. |
| K791681 | THE DENVER SPLINT | Oct 22, 1979 | Substantially Equivalent | Xomed, Inc. |
| K791053 | THE DENVER SPLINT | Aug 16, 1979 | Substantially Equivalent | Ronald D. Shippert, M.D. |
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.