Clearance Summary
DIAMOND-SHARP(R) TROCARS received FDA 510(k) clearance under submission number K924148, sponsored by Snowden-Pencer. 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 1994-02-28.
- Submission: K924148
- Applicant / Sponsor: Snowden-Pencer
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1994-02-28
Classification & Regulation
This clearance is catalogued under FDA product code HFI and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.