Choledochoscope/Endoscope Modification
FDA 510(k) K933906 · Fujinon, Inc.
510(k) numberK933906
Submission
- Device name
- Choledochoscope/Endoscope Modification
- Applicant
- Fujinon, Inc.
New York, NY, US - Received
- August 11, 1993
- Decision date
- July 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBN – Choledochoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code FBN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254153 | Single-use Video Scope; PB Digital ControllerFBN · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/03/2026SE |
| K253139 | Disposable Distal CapFBN · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 03/19/2026SE |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…FBN · Traditional | Scivita Medical Technology Co., Ltd. | 01/20/2026SE |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent…FBN · Traditional | Tangent Endoscopy, LLC | 09/12/2025SE |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)FBN · Special | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 03/07/2025SE |
| K241444 | Biliary Pancreaticobiliary Scope SystemFBN · Traditional | Shenzhen HugeMed Medical Technical Development… | 01/21/2025SE |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly…FBN · Traditional | CenterPoint Systems, LLC | 05/02/2024SE |
| K231497 | Choledochoscope SystemFBN · Traditional | Shenzhen HugeMed Medical Technical Development… | 03/06/2024SE |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)FBN · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 10/17/2023SE |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…FBN · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 06/22/2023SE |
More from Zhuhai Pusen Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2FDS · Traditional | 08/13/2012SE |
| K112391 | Fujinon ColonoscopesFDF · Special | 07/26/2012SE |
| K102466 | Fujinon EPX-4440HD Digital Video ProcessorFET · Traditional | 05/25/2011SE |
| K111243 | Fujinon Ultrasonic ProcessorFDS · Special | 05/16/2011SE |
| K091773 | Fujinon Sterile OvertubesFED · Special | 08/07/2009SE |
| K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15FDF · Traditional | 04/22/2009SE |
| K063316 | Fujinon Model EG-530N Trans Nasal InsertionFDS · Traditional | 03/16/2007SE |
| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700FDS · Traditional | 03/01/2007SE |
| K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PEOQ · Traditional | 05/19/2005SE |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5FDS · Traditional | 11/24/2004SE |
Questions and answers
When was Choledochoscope/Endoscope Modification cleared by the FDA?
Choledochoscope/Endoscope Modification (K933906) received a 510(k) decision of Substantially Equivalent on July 8, 1994, 331 days after the submission was received.
What is the product code of K933906?
The FDA product code is FBN – Choledochoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.