510(k) K221174
K221174 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "Telepack +". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Karl Storz Endoscopy America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2022
- Date Received
- April 25, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.