Clearance Summary
FMS HIGH FLOW ARTHRO-SHEATH received FDA 510(k) clearance under submission number K951702, sponsored by Future Medical Systems, 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 1995-05-12.
- Submission: K951702
- Applicant / Sponsor: Future Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1995-05-12
Classification & Regulation
This clearance is catalogued under FDA product code HNX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.