SPIWay Endonasal Access Guide
FDA 510(k) clearance K180141 · decided 2018-02-16
Clearance details
- K-number
- K180141
- Device name
- SPIWay Endonasal Access Guide
- Applicant
- Spiway, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-01-18
- Decision date
- 2018-02-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LYA
- Device class
- 1
- Regulation number
- 874.4780
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TurbAlign (K243655) | Spirair, Inc. | 2025-07-11 |
| Epi-Stop Nasal Gel/epistaxis pack (K230142) | Biomed Ent, Inc. | 2023-03-22 |
| SPIWay Endonasal Access Guide (K213153) | Spiway, LLC | 2021-10-27 |
| Novapak Nasal Sinus Packing and Stent (K202623) | Medtronic Xomed | 2020-12-08 |
| ChitoZolve (K181696) | Gyrus Acmi, Inc. | 2018-11-30 |
| Composite Removable Sinus Stent System (K170913) | Sts Medical | 2017-12-15 |
| Chitogel Endoscopic Sinus Surgery Kit (K172179) | Chitogel, Ltd. | 2017-10-17 |
| SPIWay Endonasal Access Guide (K153686) | Spiway, LLC | 2016-01-28 |
| HEMOPORE (K141816) | Polyganics B.V., | 2014-10-23 |
| NOVASHIELD INJECTABLE NASAL PACKING AND STENT (K141704) | Medtronic, Inc. | 2014-10-06 |
| NASOPORE-FD (K141423) | Polyganics B.V., | 2014-08-07 |
| ARTHROCARE NASASTENT CMC NASAL DRESSING (K140992) | ArthroCare Corporation | 2014-06-16 |
Recalls involving this device
No recalls on record reference this clearance.