SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET— 510(k) K902773
Substantially EquivalentMedical Engineering Corp.
FDA 510(k) clearance K902773 for SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET, Substantially Equivalent on 1990-07-16. Applicant: Medical Engineering Corp.. Device class: 2.
Clearance details
- Applicant
- Medical Engineering Corp.
- 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
- Racine, WI, US
Recent devices under product code FGB
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- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
More clearances from Medical Engineering Corp.
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.