510(k) K972846 ยท GXI Probe, Radiofrequency Lesion
BMC RF CANNULA
| Applicant | Baylis Medical Co., Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jul 17, 1998 |
| Received | Aug 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972846
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2014 | Kimberly-Clark Corporation Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10
The product is used to create lesions in Terminated |
GXI | None listed |
| Feb 26, 2013 | Baylis Medical Company Inc. BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white she Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.