Disposable Distal Cap— 510(k) K253139
Substantially EquivalentMirco-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K253139 for Disposable Distal Cap, Substantially Equivalent on 2026-03-19. Applicant: Mirco-Tech (Nanjing) Co., Ltd.. Device class: 2.
Summary
Mirco-Tech (Nanjing)'s Disposable Distal Cap is filed under FBN, flexible or rigid choledochoscopes and accessories. The name is generic, and the record doesn't list sizes or models.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Mirco-Tech (Nanjing) filed from Nanjing, China. The decision came 175 calendar days after receipt (September 25, 2025 to March 19, 2026).
Clearance details
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd.
- Product code
- Product code FBN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code FBN
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- K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more
- K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
- K241444 — Biliary Pancreaticobiliary Scope System
More clearances from Mirco-Tech (Nanjing) Co., Ltd.
view allAdverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.