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 |