PLASMAKINETIC ENDOUROLOGY SYSTEM— 510(k) K003569
Substantially EquivalentGyrus Medical , Ltd.
FDA 510(k) clearance K003569 for PLASMAKINETIC ENDOUROLOGY SYSTEM, Substantially Equivalent on 2000-12-19. Applicant: Gyrus Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Gyrus Medical , Ltd.
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cardiff, Wales, GB
Recent devices under product code KNS
view allMore clearances from Gyrus Medical , Ltd.
view all- K041285 — GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
- K001270 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
- K994166 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
- K993749 — GYRUS HYSTEROSCOPIC RESECTOSCOPE
- K990628 — GYRUS ENDOUROLOGY SYSTEM
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.