K221608 is an FDA 510(k) clearance for the NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether. This device is classified as a Magnetically Maneuvered Capsule Endoscopy System (Class II - Special Controls, product code QKZ).
Submitted by Anx Robotica Corp (Plano, US). The FDA issued a Cleared decision on November 22, 2022, 172 days after receiving the submission on June 3, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1310. A Magnetically Maneuvered Capsule Endoscopy System Consists Of An Ingestible Capsule And Magnetic Controller And Is Used For Visualization Of The Stomach And Duodenum. The Ingestible Capsule Contains A Camera That Wirelessly Captures Images Of The Mucosa. The Magnetic Controller Is Used Outside Of The Patient And Is Magnetically Coupled With The Capsule To Control Its Location And Viewing Direction..
| 510(k) Number | K221608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2022 |
| Decision Date | November 22, 2022 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QKZ - Magnetically Maneuvered Capsule Endoscopy System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1310 |
| Definition | A Magnetically Maneuvered Capsule Endoscopy System Consists Of An Ingestible Capsule And Magnetic Controller And Is Used For Visualization Of The Stomach And Duodenum. The Ingestible Capsule Contains A Camera That Wirelessly Captures Images Of The Mucosa. The Magnetic Controller Is Used Outside Of The Patient And Is Magnetically Coupled With The Capsule To Control Its Location And Viewing Direction. |