SeptAlign
FDA 510(k) clearance K233569 · decided 2024-03-22
Clearance details
- K-number
- K233569
- Device name
- SeptAlign
- Applicant
- Spirair, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-06
- Decision date
- 2024-03-22
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- NHB
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- South San Francisco, 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 |
|---|---|---|
| SeptAlign (SPLN001) (K260620) | Spirair, Inc. | 2026-07-30 |
| SeptAlign (K251790) | Spirair, Inc. | 2026-01-16 |
| Spirair Nasal Septal Strap (K223167) | Spirair, Inc. | 2023-08-17 |
| PosiSep EAR Fragmentable Ear Dressing (K210411) | Hemostasis, LLC | 2022-05-05 |
| LATERA Absorbable Nasal Implant System (K192661) | Entellus Medical, Inc. (Aka Stryker Ent) | 2019-11-10 |
| PuraSinus (K183015) | 3-D Matrix, Inc. | 2019-04-12 |
| Latera Absorbable Nasal Implant (K161191) | Spirox, Inc. | 2016-06-23 |
| INEX Absorbable Nasal Implant (K152958) | Spirox, Inc. | 2015-12-04 |
| SPIROX INEX DEVICE (K132920) | Spirox, Inc. | 2014-06-10 |
| MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (K122434) | Medtronic Xomed | 2012-10-31 |
| PDS PLATES (K092590) | ETHICON, Inc. | 2010-02-17 |
| NASOPORE EAR (K070715) | Polyganics B.V., | 2007-05-07 |
Recalls involving this device
No recalls on record reference this clearance.