Clearance Summary
ENDOPATH TISSUE RETAINING COMPONENT received FDA 510(k) clearance under submission number K923679, sponsored by Ethicon Endo-Surgery, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1992-09-09.
- Submission: K923679
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1992-09-09
Classification & Regulation
This clearance is catalogued under FDA product code KCJ and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.