510(k) K201096
K201096 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "CO2mbiLED". The FDA issued a decision of Substantially Equivalent on June 23, 2020. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), 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
- June 23, 2020
- Date Received
- April 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Automatic Carbon-Dioxide For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type