Clearance Summary
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF received FDA 510(k) clearance under submission number K912398, sponsored by ETHICON, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1991-12-17.
- Submission: K912398
- Applicant / Sponsor: ETHICON, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1991-12-17
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.