The following data is part of a premarket notification filed by Peak Surgical, Inc. with the FDA for Peak Plasmablade Plus Tissue Dissection Device.
| Device ID | K102709 |
| 510k Number | K102709 |
| Device Name: | PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | An Nguyen |
| Correspondent | An Nguyen PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2010-12-17 |
| Summary: | summary |