Clearance Summary
ENDOPATH ENDOSCOPIC INSTRUMENTS received FDA 510(k) clearance under submission number K984240, sponsored by Ethicon Endo-Surgery, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1999-06-22.
- Submission: K984240
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1999-06-22
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.