The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Electrosurgical Probe.
| Device ID | K963901 |
| 510k Number | K963901 |
| Device Name: | ELECTROSURGICAL PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Elizabeth A Ryan |
| Correspondent | Elizabeth A Ryan SMITH & NEPHEW ENDOSCOPY, 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 | 1996-09-27 |
| Decision Date | 1996-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885554008139 | K963901 | 000 |
| 23596010252191 | K963901 | 000 |
| 23596010538639 | K963901 | 000 |
| 23596010468431 | K963901 | 000 |
| 23596010252221 | K963901 | 000 |
| 23596010252214 | K963901 | 000 |
| 23596010252207 | K963901 | 000 |