RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more— 510(k) K233275
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K233275 for RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more, Substantially Equivalent on 2024-03-25. Applicant: Gyrus Acmi, Inc.. Device class: 2.
Clearance details
- Device name as filed
- RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
- Applicant
- Gyrus Acmi, Inc.
- 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
- Brooklyn Park, MN, US
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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.