Chrysalis Intelligence · Product Codes · FDT

FDT · Duodenoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology · 13 clearances · 5 unique sponsors

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Device class
Class II
Regulation 876.1500
Total clearances
13
2020-01-17 → 2026-03-09
Last 12 months
3
Unique sponsors
5
Definition

What is Duodenoscope And Accessories, Flexible/Rigid

To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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
Olympus Medical Systems Corp. 6 2 2026-02-22
Pentax of America, Inc. 3 0 2024-08-01
Fujifilm Corporation 2 1 2026-03-09
Ambu Innovation GmbH 1 0 2020-07-17
Ambu A/S 1 0 2024-04-16
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 covers duodenoscope procedures
43239 CPT — High EGD with biopsy specifically of duodenum
43260 CPT — Medium EGD with pancreatic or biliary sphincterotomy (ERCP-type procedure)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-09 K251861 Fujifilm Corporation FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
2026-02-22 K253646 Olympus Medical Systems Corp. Single Use Distal Cover MAJ-2315 (MAJ-2315)
2025-09-19 K251867 Olympus Medical Systems Corp. EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
2025-06-05 K250701 Olympus Medical Systems Corp. Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
2024-08-01 K233942 Pentax of America, Inc. PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
2024-04-16 K233886 Ambu A/S Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
2022-05-11 K220587 Olympus Medical Systems Corp. Evis Exera III Duodenovideoscope Olympus TJF-Q190V
2021-04-09 K210710 Pentax of America, Inc. PENTAX Medical Video Duedenoscope ED34-i10T2
2021-04-01 K202365 Pentax of America, Inc. Pentax Medical Video Duodenoscope ED32-i10
2020-12-08 K202661 Olympus Medical Systems Corp. Evis Exera III Duodenovideoscope Olympus TJF-Q190V
2020-10-30 K203028 Fujifilm Corporation FUJIFILM Distal End Cap
2020-07-17 K201098 Ambu Innovation GmbH Ambu Duodeno System
2020-01-17 K193182 Olympus Medical Systems Corp. Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence