HD-550 Video Endoscope System
FDA 510(k) clearance K222020 · decided 2022-09-08
Clearance details
- K-number
- K222020
- Device name
- HD-550 Video Endoscope System
- Applicant
- Sonoscape Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-08
- Decision date
- 2022-09-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- NWB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HD-550 Video Endoscope System (K211882) | Sonoscape Medical Corp. | 2022-04-01 |
| HD-500 Video Endoscope System (K173921) | Sonoscape Medical Corp. | 2018-09-05 |
| VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE (K133538) | Olympus Corporation of the Americas | 2014-08-07 |
| EVIS EXERAII 180 SYSTEM (K100584) | Olympus Medical Systems Corporation | 2010-07-02 |
| HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (K090980) | Olympus Winter & Ibe GmbH | 2009-06-29 |
| EVIS EXERA II 180 SYSTEM (K072957) | Olympus Medical Systems Corporation | 2008-03-18 |
| EVIS EXERA II 180 SYSTEM (K062049) | Olympus Medical Systems Corporation | 2006-09-22 |
| EVIS EXERA 160A SYSTEM (K051645) | Olympus Medical Systems Corporation | 2005-10-13 |
Recalls involving this device
No recalls on record reference this clearance.