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Asp ASPGSOLO25

by Sedatelec

Asp ASPGSOLO25 (110634), an acupuncture needle (FDA Class II; FDA product code MQX, Needle, Acupuncture, Single Use) made by Sedatelec, was cleared under FDA 510(k) K060392 on 26 Apr 2006 and listed in FDA GUDID on 22 Sep 2016 (UDI-DI 03760262490472); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K060392

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 Number03760262490472 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) from GUDID NumberK060392 Date26 Apr 2006IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060392 decided 26 Apr 2006 Active
  • FDA GUDID UDI-DI 03760262490472 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060392
  2. Listed FDA GUDID 03760262490472

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Asp
Generic name
Acupuncture needle, single-use
Model / Ref / Catalog
ASPGSOLO25, 110634
Primary DI / UDI-DI
03760262490472
510(k) Number
FDA product code
MQX
GMDN term
Acupuncture needle, single-use
Device class
Class II
Regulation number
880.5580
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K060392)

Similar devices

Other devices filed under FDA product code MQX (Needle, Acupuncture, Single Use).

Other devices from Sedatelec

See all devices from Sedatelec →

Properties

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