510(k) K082786 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
| Applicant | Peak Surgical, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Dec 3, 2008 |
| Received | Sep 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082786
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2011 | Peak Surgical PEAK brand PlasmaBlade EXT, Tissue Dissection Device,
Catalogue Number: PS215-040;
Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA
The PEAK Surgery System is indicated for th Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.