| Device Type ID | 1606 |
| Device Name | Splint, Intranasal Septal |
| Regulation Description | Intranasal Splint. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 874.4780 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LYA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1606 |
| Device | Splint, Intranasal Septal |
| Product Code | LYA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Intranasal Splint. |
| CFR Regulation Number | 874.4780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYRUS ACMI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POLYGANICS BV | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPIWAY LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPIWAY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Packaging Problem | 6 |
Insufficient Information | 2 |
Residue After Decontamination | 2 |
Appropriate Term/Code Not Available | 2 |
Device Dislodged Or Dislocated | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Integrity Problem | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Microbial Contamination Of Device | 1 |
Unintended Movement | 1 |
Unsealed Device Packaging | 1 |
| Total Device Problems | 29 |