Chrysalis Intelligence · Product Codes · FDF

FDF · Colonoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology · 29 clearances · 18 unique sponsors

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Device class
Class II
Regulation 876.1500
Total clearances
29
2020-01-03 → 2026-09-03
Last 12 months
5
Unique sponsors
18
Definition

What is Colonoscope And Accessories, Flexible/Rigid

To examine or perform procedures in the colon or rectum 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
Motus GI Medical Technologies , Ltd. 3 0 2023-10-20
Lumendi, LLC 3 0 2023-02-10
Smart Medical Systems , Ltd. 3 0 2022-04-11
Olympus Medical Systems Corp. 2 0 2025-05-15
Actuated Medical, Inc. 2 0 2024-10-04
Gi View , Ltd. 2 1 2026-08-21
Bpendo, LLC 2 1 2026-07-02
Fujifilm Corporation 2 0 2025-05-23
Endorobotics Co., Ltd. 1 0 2025-09-24
Shanghai SeeGen Photoelectric Technology Co., Ltd. 1 1 2026-01-30
Pentax of America, Inc. 1 0 2025-01-03
Hangzhou AGS MedTech Co., Ltd. 1 0 2022-04-06
Ambu A/S 1 0 2023-09-15
Era Endoscopy S.R.L. 1 0 2020-01-03
Saneso, Inc. 1 0 2022-04-01
Neptune Medical, Inc. 1 1 2026-09-03
Yangzhou Fartley Medical Instrument Technology Co., Ltd. 1 1 2026-05-28
Guangzhou Red Pine Medical Instrument Co., Ltd. 1 0 2024-02-16
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
45378 CPT — High Diagnostic colonoscopy without biopsy
45398 CPT — High Colonoscopy with biopsy is standard billing for flexible colonoscope
45380 CPT — Medium Colonoscopy with removal of polyp by snare
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-03 K260503 Neptune Medical, Inc. Triton 1 System
2026-08-21 K261015 Gi View, Ltd. Solo Scope Colonoscope System
2026-07-02 K261587 BPEndo, LLC Insufflation Retention Device (IRD) (11173-325-101)
2026-05-28 K260423 Yangzhou Fartley Medical Instrument Technology Co., Ltd. Disposable Endoscopic Distal Attachments
2026-01-30 K252457 Shanghai SeeGen Photoelectric Technology Co., Ltd. Disposable Distal End Tape Hood
2025-09-24 K244029 Endorobotics Co., Ltd. ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
2025-05-23 K243261 Fujifilm Corporation FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
2025-05-15 K250432 Olympus Medical Systems Corporation Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
2025-01-03 K242110 Pentax of America, Inc. PENTAX Medical Video Colonoscope (EC38-i20cWL)
2024-10-04 K242325 Actuated Medical, Inc. GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
2024-02-16 K232043 Guangzhou Red Pine Medical Instrument Co., Ltd. Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
2023-11-03 K231254 Actuated Medical, Inc. GripTract-GI Endoscopic Tissue Manipulator
2023-10-20 K232922 Motus GI Medical Technologies , Ltd. Pure-Vu EVS System
2023-09-15 K230332 Ambu A/S Ambu® aScope™ Colon; Ambu® aBox™ 2
2023-09-08 K223827 Fujifilm Corporation FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
2023-08-17 K230588 Gi View , Ltd. Aer-O-Scope Colonoscope System
2023-02-10 K221452 Lumendi, LLC DiLumen C1, EZ1 and Tool Mount
2022-07-21 K213773 Bpendo, LLC Insufflation Retention Device
2022-04-11 K220158 Smart Medical Systems , Ltd. G-EYE System
2022-04-06 K213578 Hangzhou AGS MedTech Co., Ltd. Balloon Dilatation Catheter
2022-04-01 K210052 Saneso, Inc. Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
2022-02-10 K220007 Motus GI Medical Technologies , Ltd. Pure-Vu EVS System
2021-10-22 K211819 Lumendi, LLC DiLumen C2 and Tool Mount
2021-04-29 K210981 Motus GI Medical Technologies , Ltd. Pure Vu System
2021-04-21 K210851 Lumendi, LLC DiLumen Endolumenal Interventional Platform (DiLumen)
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence