| Device Type ID | 1600 |
| Device Name | Instrument, Ent Manual Surgical |
| Regulation Description | Ear, Nose, And Throat Manual Surgical Instrument. |
| 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 | 874.4420 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LRC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1600 |
| Device | Instrument, Ent Manual Surgical |
| Product Code | LRC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ear, Nose, And Throat Manual Surgical Instrument. |
| CFR Regulation Number | 874.4420 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCLARENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ENTELLUS MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ENTELLUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
INTUIT MEDICAL PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SINUSYS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 54 |
Detachment Of Device Or Device Component | 17 |
Material Fragmentation | 9 |
Material Rupture | 8 |
Break | 7 |
Material Separation | 6 |
Material Frayed | 6 |
Unsealed Device Packaging | 5 |
Detachment Of Device Component | 5 |
Imprecision | 5 |
Scratched Material | 5 |
Tip | 4 |
Bent | 4 |
Tear, Rip Or Hole In Device Packaging | 3 |
Deflation Problem | 3 |
Use Of Device Problem | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Integrity Problem | 2 |
Fracture | 2 |
Communication Or Transmission Problem | 2 |
Insufficient Information | 2 |
Off-Label Use | 2 |
Device Issue | 1 |
Device Damaged By Another Device | 1 |
Sticking | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Expiration Issue | 1 |
Failure To Unfold Or Unwrap | 1 |
Packaging Problem | 1 |
Temperature Problem | 1 |
Loose Or Intermittent Connection | 1 |
Positioning Problem | 1 |
Infusion Or Flow Problem | 1 |
Burst Container Or Vessel | 1 |
Failure To Advance | 1 |
Material Puncture / Hole | 1 |
Material Split, Cut Or Torn | 1 |
Contamination / Decontamination Problem | 1 |
Balloon | 1 |
Jaw | 1 |
| Total Device Problems | 174 |