SeptAlign (SPLN001)— 510(k) K260620
Substantially EquivalentSpirair, Inc.
FDA 510(k) clearance K260620 for SeptAlign (SPLN001), Substantially Equivalent on 2026-07-30. Applicant: Spirair, Inc.. Device class: 2.
Summary
SeptAlign (SPLN001) from Spirair is filed under NHB, synthetic absorbable ear, nose, and throat polymers. The record doesn't describe its form or composition beyond that code name.
Class II, 21 CFR 874.3620. Ear, Nose, and Throat is both the classification panel and the review panel. It came in as a Traditional 510(k).
Spirair filed from South San Francisco, California. The decision came 155 calendar days after receipt (February 25 to July 30, 2026).
Clearance details
- Applicant
- Spirair, Inc.
- Product code
- Product code NHB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, Ca, US
Recent devices under product code NHB
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