Cysto-Urethroscopes and accessories— 510(k) K260350
Substantially EquivalentHangzhou Hawk Optical Electronic Instruments Co., Ltd.
FDA 510(k) clearance K260350 for Cysto-Urethroscopes and accessories, Substantially Equivalent on 2026-10-26. Applicant: Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
- Product code
- Product code FJL
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code FJL
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- K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable
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- K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
More clearances from Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
view allAdverse events under product code FJL
product code FJL- Death
- 2
- Total
- 2
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.