Clearance Summary
Medical Monofilament Sensory Screening Toool received FDA 510(k) clearance under submission number K143068, sponsored by Medical Monofilament Manufacturing. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-01-14.
- Submission: K143068
- Applicant / Sponsor: Medical Monofilament Manufacturing
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1500
- Decision date: 2015-01-14
Classification & Regulation
This clearance is catalogued under FDA product code GXB and 21 CFR 882.1500, within the Neurology review panel as a Class I device.