Clearance Summary
ENDOTOME received FDA 510(k) clearance under submission number K790645, sponsored by Berkeley Bio-Engineering. 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 1979-04-23.
- Submission: K790645
- Applicant / Sponsor: Berkeley Bio-Engineering
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1979-04-23
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.