Pentax Choledochofiberscope, #FCD-15A
FDA 510(k) K821974 · Pentax Precision Instrument Corp.
510(k) numberK821974
Submission
- Device name
- Pentax Choledochofiberscope, #FCD-15A
- Applicant
- Pentax Precision Instrument Corp.
Mchenry, IL, US - Received
- July 2, 1982
- Decision date
- August 10, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K041397 | EG-3830UTITX · Traditional | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K031789 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 08/08/2003SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
Questions and answers
When was Pentax Choledochofiberscope, #FCD-15A cleared by the FDA?
Pentax Choledochofiberscope, #FCD-15A (K821974) received a 510(k) decision of Substantially Equivalent on August 10, 1982, 39 days after the submission was received.
What is the product code of K821974?
The FDA product code is FBN – Choledochoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.