The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Resection Button Electrode For Plasma Vaporization, Hf-resection Electrode Rollers And Needles, Loops And Bands.
| Device ID | K102781 |
| 510k Number | K102781 |
| Device Name: | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello |
| Correspondent | Stacy Abbatiello OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2011-01-11 |
| Summary: | summary |