510(k) K222020
K222020 is an FDA 510(k) premarket notification submitted by Sonoscape Medical Corp. for the device "HD-550 Video Endoscope System". The FDA issued a decision of Substantially Equivalent on September 8, 2022. The device falls under product code NWB (Endoscope, Accessories, Narrow Band Spectrum), a Class II device regulated under 21 CFR 876.1500. Sonoscape Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2022
- Date Received
- July 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Accessories, Narrow Band Spectrum
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.