Clearance Summary
MALE CIRCUMCISION KITS:RAPIDECLAMP received FDA 510(k) clearance under submission number K142163, sponsored by Medicfit Technology Sdn Bhd. 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 2015-04-20.
- Submission: K142163
- Applicant / Sponsor: Medicfit Technology Sdn Bhd
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2015-04-20
Classification & Regulation
This clearance is catalogued under FDA product code HFX and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.