SeptAlign (SPLN001)
by Spirair
510(k) K260620
SeptAlign (SPLN001) is a Class II device made by Spirair, cleared under FDA 510(k) K260620 on 30 Jul 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260620 | Date30 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K260620
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NHB
- FDA applicant
- Spirair, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3620
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K260620
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SeptAlign FG-0038 | SPLN001 / FG-0038 | 00860011696346 | — | On the market |
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