510(k) K221590
K221590 is an FDA 510(k) premarket notification submitted by Ankon Technologies Co., Ltd. for the device "NaviCam Small Bowel Capsule Endoscopy System". The FDA issued a decision of Substantially Equivalent on December 2, 2022. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Ankon Technologies Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2022
- Date Received
- June 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Device Class
- Class II
- Regulation Number
- 876.1300
- Review Panel
- GU
- Submission Type