NOVASHIELD INJECTABLE NASAL PACKING AND STENT
FDA 510(k) clearance K141704 · decided 2014-10-06
Clearance details
- K-number
- K141704
- Device name
- NOVASHIELD INJECTABLE NASAL PACKING AND STENT
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-24
- Decision date
- 2014-10-06
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- LYA
- Device class
- 1
- Regulation number
- 874.4780
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
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| 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 |
| SPIWay Endonasal Access Guide (K180141) | Spiway, LLC | 2018-02-16 |
| 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |