510(k) K020341
- Device
- GIVEN DIAGNOSTIC SYSTEM
- Applicant
- GIVEN IMAGING LTD.
- 510(k) number
- K020341
- Product code
- NEZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-02
- Date received
- 2002-02-01
- Regulation
- 876.1300
- Classification name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHOSHANA FRIEDMAN
- Address
- New Industrial Park P.O. Box 258 Yoqneaam IL 20692 20692
FDA Registration Numbers#
- 3002808148
- 3008361498
- 2528981
- 2518897
- 3010188783
- 1528319
- 3003637092
- 8010047
- 3011050570
- 3008062894
- 3017400296
- 9710107
- 3007244127
- 3018094310
- 3013684328
- 3016544248
Source Documents#
Other 510(k) Records For Product Code NEZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | 2026-05-08 |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 2025-12-19 |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024-12-04 |
| K240276 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) | 2024-05-10 |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corporation | 2024-01-05 |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023-06-30 |
| K221590 | NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 2022-12-02 |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021-08-27 |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2020-02-14 |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | 2019-04-19 |
| K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2019-03-05 |
| K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-11-08 |
| K173459 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2018-03-13 |
| K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-01-30 |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging , Ltd. | 2017-09-01 |
Legacy Summary#
summary
FDA Review#
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