FDS · Product Code · Chrysalis Intelligence

Sponsor	Clearances	Last 12 mo	Most recent
Fujifilm Corporation	8	2	2026-02-17
Pentax of America, Inc.	4	1	2025-12-16
EvoEndo, Inc.	4	2	2026-04-21
Ambu A/S	2	0	2024-04-05
Olympus Medical Systems Corporation	2	0	2025-05-01
Neptune Medical, Inc.	1	0	2021-05-25
Fujifilm Corporaton	1	0	2023-01-27
Alton (Shanghai) Medical Instruments Co., Ltd.	1	0	2025-05-30
Micro-Tech (Nanjing) Co., Ltd.	1	0	2025-06-27
Actuated Medical, Inc.	1	1	2025-10-31
Huizhou Xzing Technology Co., Ltd.	1	0	2020-09-02
Intuitive Surgical, Inc.	1	1	2026-08-07
FUJIFILM Healthcare Americas Corporation	1	0	2023-09-01
Iq Endoscopes Limited	1	0	2023-11-17

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
43235	CPT	—	High	Esophagogastroduodenoscopy with biopsy; standard for gastroscope procedures
43239	CPT	—	High	EGD with biopsy of stomach or duodenum
43200	CPT	—	Medium	Diagnostic esophagogastroduodenoscopy

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-07	K253702	Intuitive Surgical, Inc.	Intuitive Endoluminal Gastrointestinal System (IG1000)
2026-04-21	K260573	EvoEndo, Inc.	EvoEndo Single-Use Endoscopy System
2026-02-17	K250550	Fujifilm Corporation	FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
2026-02-06	K253568	Fujifilm Corporation	Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
2025-12-16	K251256	Pentax of America, Inc.	PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
2025-10-31	K251041	Actuated Medical, Inc.	GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
2025-10-10	K251708	EvoEndo, Inc.	EvoEndo Single-Use Endoscopy System
2025-06-27	K243388	Micro-Tech (Nanjing) Co., Ltd.	Disposable Distal Cap
2025-06-16	K250900	EvoEndo, Inc.	EvoEndo Single-Use Endoscopy System
2025-06-10	K243512	Fujifilm Corporation	FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
2025-05-30	K242635	Alton (Shanghai) Medical Instruments Co., Ltd.	Endoscopic Distal Attachment (AF-D series)
2025-05-01	K250296	Olympus Medical Systems Corp.	Disposable Distal Attachment D-201 Series
2024-12-06	K241213	Pentax of America, Inc.	PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
2024-10-11	K242779	Fujifilm Corporation	Hood (DH-083ST)
2024-09-04	K240142	Fujifilm Corporation	FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
2024-06-19	K232997	Olympus Medical Systems Corporation	EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
2024-04-05	K232919	Ambu A/S	Ambu® aScope Gastro Large; Ambu® aBox 2
2023-11-17	K232028	Iq Endoscopes Limited	Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
2023-09-01	K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
2023-01-27	K221551	Fujifilm Corporaton	FUJIFILM Endoscope Model EI-740D/S
2022-02-14	K213606	EvoEndo, Inc.	EvoEndo Single-Use Endoscopy System
2022-02-03	K212382	Ambu A/S	Ambu® aScope Gastro, Ambu® aBox2
2021-10-20	K210177	Pentax of America, Inc.	PENTAX Medical Video Upper GI Scopes EG17-J10
2021-08-19	K212296	Fujifilm Corporation	Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
2021-05-25	K210915	Neptune Medical, Inc.	Pathfinder Endoscope Cap

FDS · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances