Clearance Summary
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set received FDA 510(k) clearance under submission number K152105, sponsored by Rocket Medical Plc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-03-29.
- Submission: K152105
- Applicant / Sponsor: Rocket Medical Plc
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2016-03-29
Classification & Regulation
This clearance is catalogued under FDA product code PNG and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.