K230991 is an FDA 510(k) clearance for the PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E. This device is classified as a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II - Special Controls, product code NEZ).
Submitted by Given Imaging Ltd. (Medtronic) (Yoqneam Northern, IL). The FDA issued a Cleared decision on June 30, 2023, 85 days after receiving the submission on April 6, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K230991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2023 |
| Decision Date | June 30, 2023 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1300 |