Clearance Summary
Laparoscopic Spray Applicator with Spinning Luers received FDA 510(k) clearance under submission number K162077, sponsored by Micromedics, Inc. (D/B/A Nordson Medical). The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-08-11.
- Submission: K162077
- Applicant / Sponsor: Micromedics, Inc. (D/B/A Nordson Medical)
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-08-11
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.