OCY — Endoscopic Guidewire, Gastroenterology-Urology Class II
FDA product code OCY covers "Endoscopic Guidewire, Gastroenterology-Urology", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OCY
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153264 | medi-globe corporation | EasyPass Guidewire | May 19, 2016 |
| K151471 | terumo medical corporation | Radifocus Glidewire Endoscopic Wire | September 17, 2015 |
| K150927 | coloplast | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire | May 27, 2015 |
| K150225 | neometrics | NovaGold High Performance Guidewire | March 16, 2015 |
| K142950 | wilson-cook medical | Acrobat Calibrated Tip Wire Guide | November 5, 2014 |
| K141820 | boston scientific | JAGWIRE HIGH PERFORMANCE GUIDWIRE | October 21, 2014 |
| K142397 | lake region medical | Predicate III Guidewire | September 19, 2014 |
| K140482 | lake region medical | MANDREL GUIDEWIRE | April 8, 2014 |
| K133076 | neometrics | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | February 20, 2014 |
| K131072 | coloplast | ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE | July 9, 2013 |
| K124052 | lake region medical | OSTAVI HYDROPHILIC GUIDEWIRE | February 26, 2013 |
| K123438 | xenolith medical | XENX STONE MANAGEMENT DEVICE | January 10, 2013 |
| K123439 | neometrics | NEO ERCP GUIDEWIRE | January 3, 2013 |
| K122816 | wilson-cook medical | AXCESS SOFT TIP WIRE GUIDE | October 9, 2012 |
| K113692 | xenolith medical | XENX | August 9, 2012 |
| K091417 | terumo | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, | May 22, 2009 |
| K082536 | cook urological | COOK WIRE GUIDES | October 27, 2008 |
| K081708 | lake region mfg | TAXI ENDOSCOPIC GUIDEWIRE | August 26, 2008 |
| K080508 | lake region medical | MANDREL GUIDEWIRES OR M-WIRE | March 21, 2008 |
| K072354 | accellent | GUIDEWIRE, MODEL G-V220-3527S AND OTHERS | December 7, 2007 |