Shock Pulse-SE Lithotripsy System CYBERWAND II— 510(k) K142428
Substantially EquivalentCybersonics, Inc.
FDA 510(k) clearance K142428 for Shock Pulse-SE Lithotripsy System CYBERWAND II, Substantially Equivalent on 2014-11-13. Applicant: Cybersonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cybersonics, Inc.
- Product code
- Code FEO
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erie, PA, US
Recent devices under product code FEO
view allMore clearances from Cybersonics, Inc.
view allAdverse events under product code FEO
product code FEO- Malfunction
- 910
- Other
- 1
- Total
- 911
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 →
Recalls naming K142428
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142428.
Data sourced from openFDA. This site is unofficial and independent of the FDA.