The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Select-one Laparoscopic Electrosurgical Blade.
| Device ID | K942892 |
| 510k Number | K942892 |
| Device Name: | CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Ira D Duesler |
| Correspondent | Ira D Duesler CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1994-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405010682 | K942892 | 000 |
| 20653405010675 | K942892 | 000 |
| 20653405010644 | K942892 | 000 |
| 20653405010637 | K942892 | 000 |
| 20653405010620 | K942892 | 000 |
| 20653405010606 | K942892 | 000 |
| 20653405010583 | K942892 | 000 |
| 20653405010576 | K942892 | 000 |