Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)— 510(k) K262437
Substantially EquivalentZhejiang Geyi Medical Instrument Co., Ltd.
FDA 510(k) clearance K262437 for Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A), Substantially Equivalent on 2026-10-29. Applicant: Zhejiang Geyi Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Geyi Medical Instrument Co., Ltd.
- Product code
- Product 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
- Jiande City, CN
Recent devices under product code FGB
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- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
More clearances from Zhejiang Geyi Medical Instrument Co., Ltd.
view all- K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3) +3 more
Adverse 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.