The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Trogard Finesse Trocar System, Model 60-6050-xxx.
| Device ID | K001597 |
| 510k Number | K001597 |
| Device Name: | CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-23 |
| Decision Date | 2000-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405012044 | K001597 | 000 |
| 20653405011993 | K001597 | 000 |
| 20653405011979 | K001597 | 000 |
| 20653405011955 | K001597 | 000 |
| 20653405011931 | K001597 | 000 |
| 20653405036439 | K001597 | 000 |
| 20653405036422 | K001597 | 000 |