Chrysalis Intelligence · Product Codes · FDS

FDS · Gastroscope And Accessories, Flexible/Rigid

Gastroenterology, Urology · 32 clearances · 14 unique sponsors

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Device class
Class II
Regulation 876.1500
Total clearances
32
2020-07-06 → 2026-09-16
Last 12 months
10
Unique sponsors
14
Definition

What is Gastroscope And Accessories, Flexible/Rigid

To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.1500
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Fujifilm Corporation 8 2 2026-02-17
Pentax of America, Inc. 4 1 2025-12-16
Olympus Medical Systems Corporation 4 2 2026-08-27
EvoEndo, Inc. 4 2 2026-04-21
Ambu A/S 3 1 2026-09-16
Alton (Shanghai) Medical Instruments Co., Ltd. 1 0 2025-05-30
Micro-Tech (Nanjing) Co., Ltd. 1 0 2025-06-27
Fujifilm Corporaton 1 0 2023-01-27
Huizhou Xzing Technology Co., Ltd. 1 0 2020-09-02
Neptune Medical, Inc. 1 0 2021-05-25
Intuitive Surgical, Inc. 1 1 2026-08-07
Actuated Medical, Inc. 1 1 2025-10-31
FUJIFILM Healthcare Americas Corporation 1 0 2023-09-01
Iq Endoscopes Limited 1 0 2023-11-17
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.

CodeTypeDescriptionConfidenceRationale
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
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-16 K261400 Ambu A/S Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large
2026-08-27 K260856 Olympus Medical Systems Corporation Disposable Distal Attachment D-201-13404
2026-08-27 K260824 Olympus Medical Systems Corporation Gastrointestinal Videoscope Olympus GIF-2T1500
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® aBox™2
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence