The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Electroblade Resector.
| Device ID | K012314 |
| 510k Number | K012314 |
| Device Name: | DYONICS ELECTROBLADE RESECTOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2002-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556603314 | K012314 | 000 |
| 23596010615514 | K012314 | 000 |
| 23596010492313 | K012314 | 000 |
| 23596010492306 | K012314 | 000 |
| 23596010475552 | K012314 | 000 |
| 23596010466154 | K012314 | 000 |