Clearance Summary
PRESS TACK NEEDLE received FDA 510(k) clearance under submission number K042063, sponsored by Asia-Med GmbH & Co. Kg. - Werk Suhl. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-10-14.
- Submission: K042063
- Applicant / Sponsor: Asia-Med GmbH & Co. Kg. - Werk Suhl
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2004-10-14
Classification & Regulation
This clearance is catalogued under FDA product code MQX and 21 CFR 880.5580, within the General Hospital review panel as a Class II device.