PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
Given Imaging Ltd. (D.B.A. Medtronic) · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Yoqneam Northern
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 2 Hacarmel St. New Industrial Park
- Address 2
- P.O. Box 258
- Statement or summary
- Summary
- Product code
- NEZ
- Zip code
- 20692
- Applicant
- Given Imaging Ltd. (D.B.A. Medtronic)
- Decision date
- 2024-05-10
- Decision code
- SESE
- Country code
- IL
- Device name
- PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- Advisory committee
- GU
- Contact
- Aaron Niklaus
- K number
- K240276
- Date received
- 2024-01-31
- Review advisory committee
- GU
- Postal code
- 20692
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1300
- Device class
- 2
- Registration number
- 3010188783, 3017400296, 1528319, 3008062894, 3011050570, 9710107, 3018094310, 3013684328, 3016544248, 3007244127, 3002808148, 3008361498, 2518897, 8010047, 2528981, 3003637092
- FEI number
- 3010188783, 3008062894, 3011050570, 3002807795, 3018094310, 3013684328, 3016544248, 3003348376, 3007244127, 3002808148, 3008361498, 1000122656, 1000080301, 3017400296, 2528981, 3003637092