The following data is part of a premarket notification filed by Laserscope with the FDA for Nessy Surestick(tm)/standard Surestick(tm).
| Device ID | K925130 |
| 510k Number | K925130 |
| Device Name: | NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Donna Page |
| Correspondent | Donna Page LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-03-18 |