Clearance Summary
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) received FDA 510(k) clearance under submission number K970873, sponsored by American Medical Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-05-20.
- Submission: K970873
- Applicant / Sponsor: American Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1997-05-20
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.