The following data is part of a premarket notification filed by Nuortho Surgical, Inc with the FDA for Ceruleau Electrosurgical Probe.
| Device ID | K101711 |
| 510k Number | K101711 |
| Device Name: | CERULEAU ELECTROSURGICAL PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NUORTHO SURGICAL, INC 161 LITTLE BAY ROAD Newington, NH 03801 |
| Contact | Martin J Leighton |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2010-07-01 |
| Summary: | summary |