510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K251790Substantially Equivalent

SeptAlign

Spirair, Inc, South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251790 is the FDA 510(k) clearance record for SeptAlign, a class II device, cleared for Spirair, Inc. on under FDA product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable). FDA's definition for product code NHB reads: "Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by...". FDA records list 5 510(k) clearances for Spirair, Inc., from to . As of , FDA records show no recalls naming K251790.

Clearance record

Decision date
Received
(219 days to decision)
Product code
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Spirair, Inc. 415 Grand Ave., South San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHB

Trailing 12 months
2 clearances under product code NHB in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NHB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260