Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Cybersonics with 7 510(k) clearances. The most recent is a 510(k) clearance dated Aug 21, 2017: ShockPulse-SE Lithotripsy System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 21, 2017 | ShockPulse-SE Lithotripsy SystemK171024 · FEO | 510(k) clearances |
| Nov 13, 2014 | Shock Pulse-SE Lithotripsy System CYBERWAND IIK142428 · FEO | 510(k) clearances |
| Nov 26, 2013 | CYBERWAND STERILE PROBE SETK132795 · FFK | 510(k) clearances |
| Jun 5, 2012 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEMK120303 · FFK | 510(k) clearances |
| Aug 30, 2010 | CYBERWAND LITHOTRIPTERK102169 · FFK | 510(k) clearances |
| Oct 24, 2007 | CYBERWAND STERILE PADS, MODEL: CW-RBPBXK072422 · FFK | 510(k) clearances |
| Dec 20, 2005 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTERK052135 · FFK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
