Clearance Summary
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION received FDA 510(k) clearance under submission number K083598, sponsored by KARL STORZ Endoscopy-America, Inc.. 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 2009-05-29.
- Submission: K083598
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-05-29
Classification & Regulation
This clearance is catalogued under FDA product code ODA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.