HD-550 Video Endoscope System
FDA 510(k) K211882 · Sonoscape Medical Corp.
510(k) numberK211882
Submission
- Device name
- HD-550 Video Endoscope System
- Applicant
- Sonoscape Medical Corp.
Shenzhen, CN - Received
- June 21, 2021
- Decision date
- April 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NWB – Endoscope, Accessories, Narrow Band Spectrum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code NWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222020 | HD-550 Video Endoscope SystemNWB · Traditional | Sonoscape Medical Corp. | 09/08/2022SE |
| K173921 | HD-500 Video Endoscope SystemNWB · Traditional | Sonoscape Medical Corp. | 09/05/2018SE |
| K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…NWB · Traditional | Olympus Corporation of the Americas | 08/07/2014SE |
| K100584 | Evis Exeraii 180 SystemNWB · Traditional | Olympus Medical Systems Corporation | 07/02/2010SE |
| K090980 | HD Endoeye, Models WA50011A, WA50013A, WA50013L, WA50013T, WA50015LNWB · Traditional | Olympus Winter & Ibe GmbH | 06/29/2009SE |
| K072957 | Evis Exera II 180 SystemNWB · Traditional | Olympus Medical Systems Corporation | 03/18/2008SE |
| K062049 | Evis Exera II 180 SystemNWB · Traditional | Olympus Medical Systems Corporation | 09/22/2006SE |
| K051645 | Evis Exera 160A SystemNWB · Traditional | Olympus Medical Systems Corporation | 10/13/2005SE |
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| K221140 | P20 Elite Series Digital Color Doppler Ultrasound SystemIYN · Traditional | 09/13/2022SE |
| K222020 | HD-550 Video Endoscope SystemNWB · Traditional | 09/08/2022SE |
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemIYN · Traditional | 07/30/2020SE |
Questions and answers
When was HD-550 Video Endoscope System cleared by the FDA?
HD-550 Video Endoscope System (K211882) received a 510(k) decision of Substantially Equivalent on April 1, 2022, 284 days after the submission was received.
What is the product code of K211882?
The FDA product code is NWB – Endoscope, Accessories, Narrow Band Spectrum, a Class II (moderate risk) device regulated under 21 CFR 876.1500.