Medical Video Endoscope [Standard Deflection] (URS3005) +6 more— 510(k) K250049
Substantially EquivalentSeplou (Zhuhai) Co., Ltd.
FDA 510(k) clearance K250049 for Medical Video Endoscope [Standard Deflection] (URS3005) +6 more, Substantially Equivalent on 2025-08-26. Applicant: Seplou (Zhuhai) Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)
- Applicant
- Seplou (Zhuhai) Co., Ltd.
- Product code
- Code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhuhai, CN
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More clearances from Seplou (Zhuhai) Co., Ltd.
view allAdverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
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.