ASP

SEDATELEC · Model ASPG8 · UDI-DI 03760262490465

MQX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear. It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation. A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle. The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.

Recalls

Date	Firm	Reason
2007-11-28	Marknew Products	Marketed without 510(k)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.