Clearance Summary
Single Use Arthroscopic Electrode (with Pencil) received FDA 510(k) clearance under submission number K170703, sponsored by Modern Medical Equipment Manufacturing Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-05-31.
- Submission: K170703
- Applicant / Sponsor: Modern Medical Equipment Manufacturing Limited
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2018-05-31
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.