PillCam? Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
Given Imaging Ltd. (D.B.A. Medtronic)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9710107 | 3003348376 | GIVEN IMAGING LTD. | 1 | N | 2026-01-01 | 2 Hacarmel St. NEW INDUSTRIAL Park, POB 258 Yoqneam Northern IL 2069204 |
| 3003141635 | 3003141635 | GIVEN IMAGING INC. | 1 | Y | 2020-04-25 | 15 Hampshire Street Mansfield MA US 02048 |
| 3005344223 | 3005344223 | Given Imaging Los Angeles | 1 | Y | 2020-04-25 | 5860 Uplander Way Culver City Culver City CA US 90230 |
| 3016099070 | 3016099070 | Given Imaging Ltd | 1 | N | 2020-04-25 | 7 Hamarpe St.P.O. Box 45025 Jerusalem Yerushalayim IL 9777407 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290101366478 | RAPID - WS, Dell T5810 V8.3 US | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290101366751 | PillCam - PillCam Software v9.0, USA | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290101366768 | PillCam - PillCam Software Upgrade v9 , USA | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290101366904 | Pillcam - recorder DR3 SW upgrade | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290110360191 | PillCam - PillCam™ Software v9.0 for WS, USA | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290110360214 | PillCam - PillCam™ Web Software v9, USA | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290110360221 | PillCam - PillCam™ WS v9 Dell T5810, USA | +1(508)261-8000 | covidien.udi@covidien.com |
| 07290110360719 | PillCam - PillCam™ Recorder DR3 SW upgrade | +1(508)261-8000 | covidien.udi@covidien.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 332181 | 1519345671 | K240276 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | NEZ | 2024-05-10 |
| 332181 | 1200810190 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | NEZ | 2023-06-30 |
| 332181 | 1302954467 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | NEZ | 2021-08-27 |
| 332181 | 1752001067 | K180171 | PillCam Patency System | NSI | 2018-03-08 |
| 332181 | 1510827414 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | NEZ | 2017-09-01 |
| 332181 | 1054419567 | K153466 | PillCam COLON 2 Capsule Endoscopy System | PGD | 2016-01-14 |
| 137145 | 1911061517 | K151086 | ManoScan System | FFX | 2016-04-28 |
| 332181 | 1993921557 | K151086 | ManoScan System | FFX | 2016-04-28 |
| 332181 | 1280280542 | K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | NEZ | 2014-12-17 |
| 137145 | 1370077878 | K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | NEZ | 2013-08-12 |
| 235568 | 1370077878 | K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | NEZ | 2013-08-12 |
| 332181 | 1967077710 | K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | NEZ | 2013-08-12 |
| 332181 | 1088392787 | K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | FFT | 2010-12-01 |
| 332181 | 1751524723 | K092342 | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | NYV | 2009-10-30 |
| 137145 | 1250935506 | ||||
| 332181 | 1319270287 |
Given Imaging Ltd. (D.B.A. Medtronic)
Given Imaging Ltd. (Medtronic)
Given Imaging Ltd. (Medtronic)
Given Imaging Ltd.
Given Imaging Ltd.
Given Imaging Ltd.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
GIVEN IMAGING LTD.
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