Olympus Small Intestinal Capsule Endoscope System
FDA 510(k) K183053 · Olympus Medical Systems Corp.
510(k) numberK183053
Submission
- Device name
- Olympus Small Intestinal Capsule Endoscope System
- Applicant
- Olympus Medical Systems Corp.
Hachioji-Shi, JP - Received
- November 2, 2018
- Decision date
- March 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code NEZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | 06/24/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was Olympus Small Intestinal Capsule Endoscope System cleared by the FDA?
Olympus Small Intestinal Capsule Endoscope System (K183053) received a 510(k) decision of Substantially Equivalent on March 5, 2019, 123 days after the submission was received.
What is the product code of K183053?
The FDA product code is NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.