510(k) K953494 ยท GEX Powered Laser Surgical Instrument
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 14, 1995 |
| Received | Jul 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953494
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.