NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule

Device class

Class II

Regulation 876.1300

Total clearances

2020-02-14 → 2026-05-08

Last 12 months

Unique sponsors

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.1300

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
CapsoVision, Inc.	3	1	2025-12-19
Given Imaging Ltd. (Medtronic)	2	0	2023-06-30
Given Imaging Ltd. (D.B.A. Medtronic)	1	0	2024-05-10
Anx Robotica Corporation	1	0	2024-01-05
Intromedic Co., Ltd.	1	1	2026-05-08
Ankon Technologies Co., Ltd.	1	0	2022-12-02

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
91110	CPT	—	High	Gastrointestinal tract imaging, intraluminal (endoscopy), wireless capsule

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-08	K252617	Intromedic Co., Ltd.	MiroCam® Capsule Endoscope System
2025-12-19	K252480	CapsoVision, Inc.	CE Deliver (DLV)
2024-12-04	K242643	CapsoVision, Inc.	CapsoCam Plus (SV-3) Capsule Endoscopy System
2024-05-10	K240276	Given Imaging Ltd. (D.B.A. Medtronic)	PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
2024-01-05	K233229	Anx Robotica Corporation	NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
2023-06-30	K230991	Given Imaging Ltd. (Medtronic)	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
2022-12-02	K221590	Ankon Technologies Co., Ltd.	NaviCam Small Bowel Capsule Endoscopy System
2021-08-27	K211684	Given Imaging Ltd. (Medtronic)	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
2020-02-14	K192662	CapsoVision, Inc.	CapsoCam Plus (SV-3) Capsule Endoscopy System