The following data is part of a premarket notification filed by T. Korossurgical Instruments Corp. with the FDA for Reusable Endoscopic Scissors, Grasper-monopolar.
| Device ID | K926583 |
| 510k Number | K926583 |
| Device Name: | REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | T. KOROSSURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorepark, CA 93021 |
| Contact | Tibor Koros |
| Correspondent | Tibor Koros T. KOROSSURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorepark, CA 93021 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-18 |
| Decision Date | 1993-08-06 |