Clearance Summary
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT received FDA 510(k) clearance under submission number K840831, sponsored by Cabot Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1984-04-04.
- Submission: K840831
- Applicant / Sponsor: Cabot Medical Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1984-04-04
Classification & Regulation
This clearance is catalogued under FDA product code HSZ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.