510(k) K233493 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3
| Applicant | Relign Corporation, Campbell CA, US |
| Decision | Substantially Equivalent, Nov 28, 2023 |
| Received | Oct 30, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233493
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.