The following data is part of a premarket notification filed by Circon Corp. with the FDA for Vaportrode Vaporization Electrode -grooved/fluted/spiked(gve-b,gve-f,gve-s) & Vaportomme Vaporization Loop (gve-lg).
| Device ID | K964594 |
| 510k Number | K964594 |
| Device Name: | VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | CIRCON CORP. 300 STILLWATER AVE. Stamford, CT 06902 -3695 |
| Contact | Ervin F Taylor, P.e. |
| Correspondent | Ervin F Taylor, P.e. CIRCON CORP. 300 STILLWATER AVE. Stamford, CT 06902 -3695 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-08-15 |