FDA product code FBN: Choledochoscope And Accessories, Flexible/Rigid
FBN is the FDA product code for choledochoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 43 510(k) submissions under FBN, 12 in the last five years, from 26 different applicants. The average 510(k) review took 146 days (median 113); 191 days on average over the last three years. FDA has posted 9 recalls for FBN devices, 4 initiated in the last five years.
Definition
to examine and perform procedures within the bile ducts. 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
| Field | Value |
|---|---|
| Device name | Choledochoscope And Accessories, Flexible/Rigid |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FBN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 83 |
| 2019 | 1 | 27 |
| 2020 | 1 | 84 |
| 2023 | 4 | 219 |
| 2024 | 2 | 224 |
| 2025 | 3 | 169 |
| 2026 | 3 | 181 |
Compare with all 510(k) review times · Search every FBN clearance
Top FBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corporation | 5 | 2010-03-10 |
| Boston Scientific Corporation | 4 | 2020-05-21 |
| KARL STORZ Endoscopy-America, Inc. | 3 | 1997-10-08 |
| Pentax Precision Instrument Corp. | 3 | 1995-11-03 |
| Mirco-Tech (Nanjing) Co., Ltd. | 2 | 2026-04-03 |
21 more applicants have FBN clearances. See the full list in Caduvo.
Most recent FBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254153 | Mirco-Tech (Nanjing) Co., Ltd. | Single-use Video Scope; PB Digital Controller | 2026-04-03 | 102 |
| K253139 | Mirco-Tech (Nanjing) Co., Ltd. | Disposable Distal Cap | 2026-03-19 | 175 |
| K251338 | Scivita Medical Technology Co., Ltd. | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | 2026-01-20 | 265 |
| K251170 | Tangent Endoscopy, LLC | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | 2025-09-12 | 150 |
| K243535 | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | 2025-03-07 | 112 |
Recalls for FBN devices
9 product recalls in 8 recall events; 4 initiated in the last five years and 3 still open. Most recent: 2026-03-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FBN?
FBN is the FDA product code for choledochoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FBN?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FBN?
Across 43 cleared submissions the average was 146 days from receipt to decision (median 113).
Which companies have the most FBN clearances?
Olympus Medical Systems Corporation (5); Boston Scientific Corporation (4); KARL STORZ Endoscopy-America, Inc. (3); Pentax Precision Instrument Corp. (3); Mirco-Tech (Nanjing) Co., Ltd. (2).
Have FBN devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2026-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code FBN
- Run a recall and safety report across every FBN manufacturer
- Watch product code FBN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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