Peak Surgical, Inc.
Palo Alto, CA, US
Peak Surgical, Inc. appears in FDA device records in Palo Alto, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Peak Surgical, Inc. between 2008 and 2011. The busiest year on record is 2010, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103775 | PEAK SUCTION COAGULATOR | GEI | Substantially Equivalent | |
| K102709 | PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | |
| K102029 | PEAK PULSAR II GENERATOR MODEL PS100-102 | GEI | Substantially Equivalent | |
| K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | |
| K083415 | PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | |
| K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES | GEI | Substantially Equivalent | |
| K073057 | PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1022-2011 | 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 the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures. | A customer reported that a patient suffered a burn while using the device. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain