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TurbAlign FG-1000

by Spirair 2 variants

TurbAlign FG-1000 (TBLN001) is a Class I device made by Spirair, cleared under FDA 510(k) K243655 on 11 Jul 2025 and listed in FDA GUDID since 14 Oct 2026 (UDI-DI 00860011696353), active as of 2 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 2 Nov 2026

Documents

510(k) K243655

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860011696353 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243655 Date11 Jul 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243655 decided 11 Jul 2025 Active
  • FDA GUDID UDI-DI 00860011696353 listed 14 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243655
  2. Listed FDA GUDID 00860011696353

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TurbAlign
Generic name
Intranasal splint, biodegradable
Model / Ref / Catalog
FG-1000, TBLN001
Primary DI / UDI-DI
00860011696353
510(k) Number
FDA product code
LYA
GMDN term
Intranasal splint, biodegradable
Device class
Class I
Regulation number
874.4780
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243655)

Similar devices

Other devices filed under FDA product code LYA (Splint, Intranasal Septal).

Other devices from Spirair

See all devices from Spirair →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)