Clearance Summary
DISPOSABLE SUCTION AND IRRIGATION SYSTEM received FDA 510(k) clearance under submission number K093479, sponsored by Modern Medical Equipment Mfg., Ltd.. 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 2010-05-19.
- Submission: K093479
- Applicant / Sponsor: Modern Medical Equipment Mfg., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4370
- Decision date: 2010-05-19
Classification & Regulation
This clearance is catalogued under FDA product code FHF and 21 CFR 876.4370, within the Gastroenterology, Urology review panel as a Class II device.