Clearance Summary
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES received FDA 510(k) clearance under submission number K113062, sponsored by Endoservice Optical Instruments 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 2012-08-21.
- Submission: K113062
- Applicant / Sponsor: Endoservice Optical Instruments GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2012-08-21
Classification & Regulation
This clearance is catalogued under FDA product code FBP and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.