Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
FDA 510(k) K233752 · CenterPoint Systems, LLC
510(k) numberK233752
Submission
- Device name
- Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
- Applicant
- CenterPoint Systems, LLC
West Valley City, UT, US - Received
- November 22, 2023
- Decision date
- May 2, 2024
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K222261 | Flexible Video-Choledochoscope SystemFBN · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 04/20/2023SE |
More from Shanghai SeeGen Photoelectric Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262240 | SSPC NXT Delivery CatheterDQY · Special | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | 07/29/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | 06/05/2026SE |
| K260942 | AuST Steerable SheathDYB · Special | 04/07/2026SE |
| K260163 | AuST CSP IntroducerDYB · Special | 02/19/2026SE |
| K250147 | CPS Locator 3D Delivery CatheterDQY · Traditional | 08/22/2025SE |
| K250828 | CPS Locator 3D Plus Delivery CatheterDQY · Special | 06/27/2025SE |
| K250492 | FlexiGo 3D Delivery CatheterDQY · Special | 06/18/2025SE |
| K251051 | AuST Steerable SheathDYB · Special | 04/30/2025SE |
| K243180 | SSPC NXT Delivery CatheterDQY · Special | 12/04/2024SE |
Questions and answers
When was Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps cleared by the FDA?
Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps (K233752) received a 510(k) decision of Substantially Equivalent on May 2, 2024, 162 days after the submission was received.
What is the product code of K233752?
The FDA product code is FBN – Choledochoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.