Given Diagnostics System
FDA 510(k) K022362 · Given Imaging , Ltd.
510(k) numberK022362
Submission
- Device name
- Given Diagnostics System
- Applicant
- Given Imaging , Ltd.
Yoqneaam, IL - Received
- July 22, 2002
- Decision date
- August 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1300
- Specialty
- Gastroenterology, Urology
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| K252617 | MiroCam® Capsule Endoscope SystemNEZ · Special | Intromedic Co., Ltd. | 05/08/2026SE |
| K252480 | CE Deliver (DLV)NEZ · Traditional | CapsoVision, Inc. | 12/19/2025SE |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemNEZ · Traditional | CapsoVision, Inc. | 12/04/2024SE |
| K240276 | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareNEZ · Traditional | Given Imaging Ltd. (D.B.A. Medtronic) | 05/10/2024SE |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherNEZ · Traditional | Anx Robotica Corporation | 01/05/2024SE |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ · Special | Given Imaging Ltd. (Medtronic) | 06/30/2023SE |
| K221590 | NaviCam Small Bowel Capsule Endoscopy SystemNEZ · Traditional | Ankon Technologies Co., Ltd. | 12/02/2022SE |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ · Traditional | Given Imaging Ltd. (Medtronic) | 08/27/2021SE |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemNEZ · Traditional | CapsoVision, Inc. | 02/14/2020SE |
| K183192 | CapsoCam Plus (SV-3)NEZ · Special | CapsoVision, Inc. | 04/19/2019SE |
More from CapsoVision, Inc.
| 510(k) | Device | Decision |
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| K180171 | PillCam Patency SystemNSI · Traditional | 03/08/2018SE |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0NEZ · Traditional | 09/01/2017SE |
| K170839 | RAPID WebNEZ · Traditional | 05/26/2017SE |
| K151086 | ManoScan SystemFFX · Traditional | 04/28/2016SE |
| K153466 | PillCam COLON 2 Capsule Endoscopy SystemPGD · Traditional | 01/14/2016SE |
| K140284 | Given Pillcam Ugi Capsule Endoscopy SystemNEZ · Traditional | 12/17/2014SE |
| K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemNEZ · Traditional | 08/12/2013SE |
| K103025 | Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesNEZ · Traditional | 05/13/2011SE |
| K101250 | Given Pillcam Platform with Pillcam SB CapsulesNEZ · Traditional | 03/07/2011SE |
| K103088 | Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R SensorbeltNEZ · Traditional | 01/14/2011SE |
Questions and answers
When was Given Diagnostics System cleared by the FDA?
Given Diagnostics System (K022362) received a 510(k) decision of Substantially Equivalent on August 9, 2002, 18 days after the submission was received.
What is the product code of K022362?
The FDA product code is NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.