FDA Product Code
FDA Product Code NEZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1300
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | 2026-05-08 | Special | PDF ↗ |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024-12-04 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corporation | 2024-01-05 | Traditional | PDF ↗ |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023-06-30 | Special | PDF ↗ |
| K221590 | NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 2022-12-02 | Traditional | PDF ↗ |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021-08-27 | Traditional | PDF ↗ |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | 2019-04-19 | Special | PDF ↗ |
| K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2019-03-05 | Traditional | PDF ↗ |
| K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-11-08 | Traditional | PDF ↗ |
| K173459 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2018-03-13 | Traditional | PDF ↗ |
| K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-01-30 | Traditional | PDF ↗ |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging , Ltd. | 2017-09-01 | Traditional | PDF ↗ |
| K170839 | RAPID Web | Given Imaging , Ltd. | 2017-05-26 | Traditional | PDF ↗ |
| K163495 | AdvanCE capsule endoscope delivery device | United States Endoscopy Group, Inc. | 2017-03-10 | Traditional | PDF ↗ |
| K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corp. | 2017-01-19 | Traditional | PDF ↗ |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | CapsoVision, Inc. | 2016-10-21 | Traditional | PDF ↗ |
| K151635 | CapsoCam (SV-1) | CapsoVision, Inc. | 2016-02-09 | Traditional | PDF ↗ |
| K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2015-03-17 | Traditional | PDF ↗ |
| K142680 | ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT | Olympus Medical Systems Corp. | 2015-02-08 | Traditional | PDF ↗ |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2014-12-17 | Traditional | PDF ↗ |
| K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2014-07-09 | Traditional | PDF ↗ |
| K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2014-06-30 | Traditional | PDF ↗ |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2013-08-12 | Traditional | PDF ↗ |
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-05-20 | Traditional | PDF ↗ |
| K123421 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corp. | 2013-04-29 | Traditional | PDF ↗ |
| K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-05-18 | Traditional | PDF ↗ |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | Given Imaging , Ltd. | 2011-05-13 | Traditional | PDF ↗ |
| K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | Given Imaging , Ltd. | 2011-03-07 | Traditional | PDF ↗ |
| K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT | Given Imaging , Ltd. | 2011-01-14 | Traditional | PDF ↗ |
| K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE | Given Imaging , Ltd. | 2010-09-30 | Traditional | PDF ↗ |
| K090210 | MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corporation | 2009-07-29 | Special | PDF ↗ |
| K091405 | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT | Given Imaging , Ltd. | 2009-07-29 | Special | PDF ↗ |
| K063259 | OLYMPUS CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corporation | 2007-09-14 | Traditional | PDF ↗ |
| K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM | Given Imaging , Ltd. | 2007-05-07 | Special | PDF ↗ |
| K062786 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-10-18 | Special | PDF ↗ |
| K053639 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2006-05-08 | Traditional | PDF ↗ |
| K040494 | CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 | United States Endoscopy Group, Inc. | 2004-06-23 | Traditional | PDF ↗ |
| K040248 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2004-02-17 | Special | PDF ↗ |
| K032405 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2003-10-29 | Traditional | PDF ↗ |
| K031033 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2003-07-01 | Traditional | PDF ↗ |
| K022980 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2003-02-27 | Traditional | PDF ↗ |
| K022362 | GIVEN DIAGNOSTICS SYSTEM | Given Imaging , Ltd. | 2002-08-09 | Special | PDF ↗ |
| K020341 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | 2002-05-02 | Traditional | PDF ↗ |
| DEN010002 | GIVEN DIAGNOSTIC IMAGING SYSTEM | Given Imaging , Ltd. | 2001-08-01 | Post-NSE | — |
Product code NEZ · Class II · Gastroenterology, Urology. Data: openFDA.