Clearance Summary
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE received FDA 510(k) clearance under submission number K031141, sponsored by Asap Endoscopic Products GmbH. 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 2003-06-30.
- Submission: K031141
- Applicant / Sponsor: Asap Endoscopic Products GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-06-30
Classification & Regulation
This clearance is catalogued under FDA product code FAJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.