PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E— 510(k) K230991
Substantially EquivalentGiven Imaging Ltd. (Medtronic)
FDA 510(k) clearance K230991 for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, Substantially Equivalent on 2023-06-30. Applicant: Given Imaging Ltd. (Medtronic). Device class: 2.
Clearance details
- Applicant
- Given Imaging Ltd. (Medtronic)
- Product code
- Code NEZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yoqneam Northern, IL
Recent devices under product code NEZ
view all- K252617 — MiroCam® Capsule Endoscope System
- K252480 — CE Deliver (DLV)
- K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System
- K240276 — PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
More clearances from Given Imaging Ltd. (Medtronic)
view allAdverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.