510(k) K230991
K230991 is an FDA 510(k) premarket notification submitted by Given Imaging Ltd. (Medtronic) for the device "PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E". The FDA issued a decision of Substantially Equivalent on June 30, 2023. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Given Imaging Ltd. (Medtronic) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2023
- Date Received
- April 6, 2023
- Clearance Type
- Special
- 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