510(k) K040424 ยท GEX Powered Laser Surgical Instrument
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
| Applicant | Clarus Medical, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 11, 2004 |
| Received | Feb 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2021 | Clarus Medical, Llc Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.