Chrysalis Intelligence · Product Codes · ODG

ODG · Endoscopic Ultrasound System, Gastroenterology-Urology

Gastroenterology, Urology · 13 clearances · 8 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 876.1500
Total clearances
13
2020-07-23 → 2026-07-31
Last 12 months
3
Unique sponsors
8
Definition

What is Endoscopic Ultrasound System, Gastroenterology-Urology

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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 3 0 2022-08-19
Olympus Medical Systems Corporation 2 2 2026-07-31
Boston Scientific Corporation 2 1 2026-06-17
Pentax of America, Inc. 2 0 2020-12-30
Micro-Tech (Nanjing) Co., Ltd. 1 0 2021-12-06
Onepass Medical , Ltd. 1 0 2025-07-18
Endosound, Inc. 1 0 2023-12-27
Sonoscape Medical Corp. 1 0 2024-03-08
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
43231 CPT — High Esophagogastroduodenoscopy with endoscopic ultrasound examination standard code
43232 CPT — High EGD with EUS and tissue sampling/FNA
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-31 K261183 Olympus Medical Systems Corporation EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
2026-06-17 K260428 Boston Scientific Corporation RIVOS™ EUS Access Device (M00553900)
2025-10-03 K251859 Olympus Medical Systems Corporation EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
2025-07-18 K251542 Onepass Medical , Ltd. InstaFAN
2024-03-08 K231813 Sonoscape Medical Corp. Ultrasonic Gastrovideoscope
2023-12-27 K232518 Endosound, Inc. EndoSound Vision System; EVS
2022-12-30 K223616 Boston Scientific Corporation Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
2022-08-19 K221238 Fujifilm Corporation FUJIFILM Ultrasonic Endoscope EG-740UT
2022-08-04 K221952 Fujifilm Corporation Endoscope Model EG-580UT and Endoscope Model EG-580UR
2022-06-03 K214089 Fujifilm Corporation FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
2021-12-06 K212852 Micro-Tech (Nanjing) Co., Ltd. Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
2020-12-30 K203166 Pentax of America, Inc. PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
2020-07-23 K200090 Pentax of America, Inc. PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence