Disposable Distal Cap
FDA 510(k) K253139 · Mirco-Tech (Nanjing) Co., Ltd.
510(k) numberK253139
Submission
- Device name
- Disposable Distal Cap
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- September 25, 2025
- Decision date
- March 19, 2026
- 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 |
| 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 |
| 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 |
|---|---|---|
| K260262 | Injection NeedleFBK · Traditional | 05/29/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | 04/24/2026SE |
| K254153 | Single-use Video Scope; PB Digital ControllerFBN · Traditional | 04/03/2026SE |
| K233772 | Disposable Dual Action Tissue Closure DevicePKL · Traditional | 03/19/2024SE |
Questions and answers
When was Disposable Distal Cap cleared by the FDA?
Disposable Distal Cap (K253139) received a 510(k) decision of Substantially Equivalent on March 19, 2026, 175 days after the submission was received.
What is the product code of K253139?
The FDA product code is FBN – Choledochoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.