Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)— 510(k) K262552
Substantially EquivalentScivita Medical Technology Co., Ltd.
FDA 510(k) clearance K262552 for Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B), Substantially Equivalent on 2026-08-14. Applicant: Scivita Medical Technology Co., Ltd.. Device class: 2.
Summary
Scivita Medical Technology filed a Single-use Flexible Ureteroscope, model SUV-5C-B, under product code FGB, flexible or rigid ureteroscopes and accessories.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Special 510(k).
Scivita filed from Suzhou, China. The decision came 21 calendar days after FDA received it (July 24 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Scivita Medical Technology 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
- Special
- Location
- Suzhou, CN
Recent devices under product code FGB
view all- K261447 — CVAC® Aspiration System
- 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
- K253505 — Zamenix P
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
More clearances from Scivita Medical Technology Co., Ltd.
view all- K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more
- K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P +2 more
- K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) +2 more
- K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
- K240192 — Single-use Extraction Baskets
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.