Clearance Summary
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE received FDA 510(k) clearance under submission number K862365, sponsored by Swemed Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1986-07-07.
- Submission: K862365
- Applicant / Sponsor: Swemed Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.1550
- Decision date: 1986-07-07
Classification & Regulation
This clearance is catalogued under FDA product code HIO and 21 CFR 884.1550, within the Obstetrics/Gynecology review panel as a Class I device.