The following data is part of a premarket notification filed by Peak Surgical, Inc. with the FDA for Peak Plasmablade 3.os Tissue Dissection Device.
| Device ID | K093695 |
| 510k Number | K093695 |
| Device Name: | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Lois Nakayama |
| Correspondent | Lois Nakayama 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 | 2009-11-30 |
| Decision Date | 2010-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169936706 | K093695 | 000 |
| 00643169868717 | K093695 | 000 |
| 00643169868670 | K093695 | 000 |
| 00643169868663 | K093695 | 000 |
| 00643169617162 | K093695 | 000 |
| 00643169617155 | K093695 | 000 |
| 00643169617148 | K093695 | 000 |
| 00643169531017 | K093695 | 000 |
| 00643169507869 | K093695 | 000 |