EPP · Splint, Nasal
Ear, Nose, Throat · 21 CFR 874.5800 · Class 1
Overview
| Product Code | EPP |
|---|---|
| Device Name | Splint, Nasal |
| Regulation | 21 CFR 874.5800 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Wfr/Aquaplast Corp. | Jul 29, 1994 | SESE |
| K942724 | EXTERNAL NASAL SPLINT | Micromed Development Corp. | Jul 8, 1994 | SESE |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Microbio-Medics, Inc. | Dec 8, 1989 | SESE |
| K890599 | HOOD NASAL SPLINT | Hood Laboratories | Mar 17, 1989 | SESE |
| K882244 | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | Richards Medical Co., Inc. | Jun 23, 1988 | SESE |
| K872905 | AMERICAN NASAL SPONGE | American Silk Sutures, Inc. | Sep 4, 1987 | SESE |
| K864933 | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | Exmoor Plastics , Ltd. | Mar 4, 1987 | SESE |
| K864932 | 'EXMOOR' CAWOOD NASAL SPLINTS | Exmoor Plastics , Ltd. | Mar 4, 1987 | SESE |
| K864930 | 'EXMOOR' ATKINS NASAL SPLINT | Exmoor Plastics , Ltd. | Mar 4, 1987 | SESE |
| K864934 | 'EXMOOR' SHAH SILICONE DISCS | Exmoor Plastics , Ltd. | Jan 28, 1987 | SESE |
| K863382 | CANNON NASAL SPLINT | Treace Medical, Inc. | Oct 7, 1986 | SESE |
| K862496 | MICROTEK INTRANASAL SPLINT | Microtek Medical, Inc. | Jul 14, 1986 | SESE |
| K810738 | GOODE MAGNETIC NASAL SPLINT | Xomed, Inc. | Mar 31, 1981 | SESE |
| K791681 | THE DENVER SPLINT | Xomed, Inc. | Oct 22, 1979 | SESE |
| K791053 | THE DENVER SPLINT | Ronald D. Shippert, M.D. | Aug 16, 1979 | SESE |
Top Applicants
- Exmoor Plastics , Ltd. — 4 clearances
- Xomed, Inc. — 2 clearances
- American Silk Sutures, Inc. — 1 clearance
- Hood Laboratories — 1 clearance
- Microbio-Medics, Inc. — 1 clearance
