Choledochoscope System— 510(k) K231497
Substantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.
FDA 510(k) clearance K231497 for Choledochoscope System, Substantially Equivalent on 2024-03-06. Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Product code
- 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
- Shenzhen, CN
Recent devices under product code FBN
view all- K254153 — Single-use Video Scope; PB Digital Controller
- K253139 — Disposable Distal Cap
- 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)
More clearances from Shenzhen HugeMed Medical Technical Development 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.