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Spiro 708

by Fogless International AB

Spiro 708 (708-10) is a Class II device made by Fogless International AB, cleared under FDA 510(k) K122932 on 23 Dec 2013 and listed in FDA GUDID since 31 Mar 2018 (UDI-DI 07350061231107), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K122932

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350061231107 UDI-DI Date31 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122932 Date23 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122932 decided 23 Dec 2013 Active
  • FDA GUDID UDI-DI 07350061231107 listed 31 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122932
  2. Listed FDA GUDID 07350061231107

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Spiro
Generic name
Tracheostomy tube speech valve
Model / Ref / Catalog
708, 708-10
Primary DI / UDI-DI
07350061231107
510(k) Number
FDA product code
JOH
GMDN term
Tracheostomy tube speech valve
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tracheostomy tube speech valve

Cleared under the same submission (K122932)

and 3 more cleared under K122932

Similar devices in this category

Other devices filed under Tracheostomy tube speech valve.

Other devices from Fogless International AB

See all devices from Fogless International AB →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)