Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only, not medical advice and not a procedure guide. Sources checked on 2026-10-30.
Short answer
A choledochoscope is an endoscope used to look directly inside the bile ducts. “Cholangioscope” is the same kind of device under another name: a 2016 review uses “peroral cholangioscopy (POC) or choledochoscopy” for the same technique. In FDA records it is class 2 under 21 CFR 876.1500, listed as product code FBN (the scope and accessories) and NWS (the kit).
Definition and scope
Xu and Kahaleh (Clin Exp Gastroenterol 2016) describe peroral cholangioscopy, or choledochoscopy, as allowing “direct visualization of the pancreatobiliary system for both diagnostic and therapeutic purposes”, and discuss it in the context of indeterminate biliary strictures and bile duct stones.
The FDA’s classification record for product code FBN gives the same scope in regulatory language: “Choledochoscope And Accessories, Flexible/Rigid”, with the definition “to examine and perform procedures within the bile ducts.” Medical specialty is listed as Gastroenterology and Urology.
Choledochoscope vs cholangioscope: one device, two names
The literature uses “choledochoscope”, “cholangioscope”, “choledochoscopy” and “peroral cholangioscopy (POC)” for the same field. The FDA’s own naming is “choledochoscope”, so a regulatory search or a supplier catalogue entry may use that word where a clinical paper uses “cholangioscope”. Treat them as one device family when searching records, and read the product description rather than relying on the name.
How the devices are arranged
The 2016 review describes these scope arrangements at product level only:
- Mother-baby. A very slim video cholangioendoscope is passed through the working channel of a therapeutic duodenoscope. The review notes that the first-generation mother-baby design needed two operators and was limited by scope fragility.
- Single-operator. The Spyglass system from Boston Scientific uses a 10 Fr access-and-delivery catheter (SpyScope) with a 1.2 mm working channel, a reusable fiber optic probe, and a disposable 3 Fr biopsy forceps (SpyBite). The newest model described is a digital system, Spyglass DS, with an integrated light source and camera unit.
- Direct peroral. An ultraslim upper endoscope used directly as a cholangioscope instead of a separate baby scope.
System types compared
| System type | Operators | Stated limitation | Source |
|---|---|---|---|
| Videocholangioscope, mother-baby | Two | Fragility and cost | Xu and Kahaleh 2016 |
| Single-operator cholangioscopy (Spyglass; newer digital Spyglass DS) | One | Separate light source, monitor and irrigation pump in the first-generation system | Xu and Kahaleh 2016 |
| Direct peroral cholangioscopy with an ultraslim endoscope | Not stated | Access can be technically challenging | Xu and Kahaleh 2016 |
FDA classification and reprocessing
From the openFDA device classification database (checked 2026-10-30):
- FBN: Choledochoscope And Accessories, Flexible/Rigid. Class 2, regulation 876.1500, review panel GU.
- NWS: Kit, Choledochoscope, Flexible And Rigid. Class 2, regulation 876.1500.
- Both codes carry GMP exempt flag N and third-party flag N.
21 CFR 876.1500 (Endoscope and accessories) describes a device used to provide access, illumination and observation of body cavities, hollow organs and canals, rigid or flexible, which may include an optical system. The regulation names examples such as cystoscopes, colonoscopes and ureteroscopes; it does not name the choledochoscope in the text. The device is classified under it through FDA’s product code records. The regulation’s lists of 510(k)-exempt items name things like light sources, guidewires, cleaning brushes and disinfectant basins, and choledochoscopes do not appear in them.
The FBN record carries one specific requirement: 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).
Where it matters for labs, clinics and supply records
- Scope and kit are separate FDA product codes. A record or catalogue line for FBN is the scope and accessories; NWS is the kit. The two are listed as distinct devices in the FDA database.
- Reusable flexible scopes come with reprocessing documentation. Under the FBN note, validated reprocessing instructions and validation data are part of the 510(k) submission, so that documentation is part of the premarket record for these scopes. For how reprocessing is regulated, see endoscope reprocessing and medical device reprocessing.
- The class is 2, not exempt. For the premarket pathway, see the FDA 510(k) premarket notification guide.
Common misunderstandings
- “Choledochoscope” and “cholangioscope” are different instruments. The literature uses the terms interchangeably.
- It is always a two-person system. Only the first-generation mother-baby arrangement was described as needing two operators; single-operator systems exist.
- It is always rigid, or always flexible. The FDA product code covers both flexible and rigid forms.
- The CFR names it. 21 CFR 876.1500 is a generic endoscope regulation; the choledochoscope is placed under it by product code.
FAQ
Is a cholangioscope the same as a choledochoscope?
Yes. Xu and Kahaleh (2016) use “peroral cholangioscopy (POC) or choledochoscopy” for the same technique, and the FDA lists the device as a choledochoscope.
What is FDA product code FBN?
FBN is “Choledochoscope And Accessories, Flexible/Rigid”, a class 2 device under 21 CFR 876.1500. NWS is the separate code for the choledochoscope kit.
Does a reusable choledochoscope need reprocessing data?
For reusable, flexible endoscopes under FBN, FDA states that validated reprocessing instructions and validation data must be included in the 510(k) submission (82 FR 26807).
Where does this sit among other endoscope topics?
See what is an endoscope for the general device family and what is a medical device for the regulatory definition.
Sources
- openFDA device classification API, product codes FBN and NWS, regulation 876.1500: https://api.fda.gov/device/classification.json?search=regulation_number:876.1500+AND+product_code:FBN (checked 2026-10-30).
- 21 CFR 876.1500, Endoscope and accessories: https://www.law.cornell.edu/cfr/text/21/876.1500 (checked 2026-10-30).
- Xu M-M, Kahaleh M. Recent developments in choledochoscopy: technical and clinical advances. Clin Exp Gastroenterol 2016;9:119-124: https://www.dovepress.com/recent-developments-in-choledochoscopy-technical-and-clinical-advances-peer-reviewed-article-CEG (checked 2026-10-30).
- FDA, 82 FR 26807 (9 June 2017): https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf, as cited in the FBN record.
