K211882 is an FDA 510(k) clearance for the HD-550 Video Endoscope System. This device is classified as a Endoscope, Accessories, Narrow Band Spectrum (Class II - Special Controls, product code NWB).
Submitted by Sonoscape Medical Corp. (Shenzhen, CN). The FDA issued a Cleared decision on April 1, 2022, 284 days after receiving the submission on June 21, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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..
| 510(k) Number | K211882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | April 01, 2022 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NWB — Endoscope, Accessories, Narrow Band Spectrum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | 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. |