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Asp Aspmtest

by Sedatelec

Asp Aspmtest (113207) is an acupuncture needle (FDA Class II; FDA product code MQX, Needle, Acupuncture, Single Use) made by Sedatelec, cleared under FDA 510(k) K060392 on 26 Apr 2006 and listed in FDA GUDID since 12 Jan 2023 (UDI-DI 03760262493466), 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) 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 Number03760262493466 UDI-DI Date12 Jan 2023ListedStatusListed GUDID: 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 03760262493466 listed 12 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060392
  2. Listed FDA GUDID 03760262493466

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  • Withdrawn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
ASPMTEST, 113207
Primary DI / UDI-DI
03760262493466
510(k) Number
FDA product code
MQX
GMDN term
Acupuncture needle, single-use
Device class
Class II
Regulation number
880.5580
GUDID distribution status
In Commercial Distribution

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Properties

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