Clearance Summary
TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM received FDA 510(k) clearance under submission number K915297, sponsored by Lifeguard Medical Products, 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 1992-02-11.
- Submission: K915297
- Applicant / Sponsor: Lifeguard Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1992-02-11
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.