CytoSure Urinary Access System— 510(k) K142194
Substantially EquivalentEmmy Medical
FDA 510(k) clearance K142194 for CytoSure Urinary Access System, Substantially Equivalent on 2014-12-19. Applicant: Emmy Medical. Device class: 2.
Clearance details
- Applicant
- Emmy Medical
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, ME, US
Recent devices under product code FAJ
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- K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more
- K253905 — PrimeSight UltraView System
- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
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.