The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Working Element, Resection Button Electrode For Plasma Vaporizaton, Hf-resection Electrode Loops And Bands.
| Device ID | K100275 |
| 510k Number | K100275 |
| Device Name: | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE 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 Kluesner |
| Correspondent | Stacy Kluesner 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-01 |
| Decision Date | 2010-07-01 |
| Summary: | summary |