Clearance Summary
CYSTOSCOPY/IRRIGATION SET received FDA 510(k) clearance under submission number K896211, sponsored by Westmark, Sterile Packing Systems, Inc. (Sps). 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 1990-01-18.
- Submission: K896211
- Applicant / Sponsor: Westmark, Sterile Packing Systems, Inc. (Sps)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1990-01-18
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.