Product code OCY
- Device name
- Endoscopic Guidewire, Gastroenterology-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153264 | EasyPass Guidewire | Medi-Globe Corporation | 2016-05-19 |
| K151471 | Radifocus Glidewire Endoscopic Wire | Terumo Medical Corporation | 2015-09-17 |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | Coloplast A/S | 2015-05-27 |
| K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015-03-16 |
| K142950 | Acrobat Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | 2014-11-05 |
| K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | Boston Scientific Corp | 2014-10-21 |
| K142397 | Predicate III Guidewire | Lake Region Medical | 2014-09-19 |
| K140482 | MANDREL GUIDEWIRE | Lake Region Medical | 2014-04-08 |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | Neometrics, Inc. | 2014-02-20 |
| K131072 | ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC | Coloplast A/S | 2013-07-09 |
| K124052 | OSTAVI HYDROPHILIC GUIDEWIRE | Lake Region Medical | 2013-02-26 |
| K123438 | XENX STONE MANAGEMENT DEVICE | Xenolith Medical | 2013-01-10 |
| K123439 | NEO ERCP GUIDEWIRE | Neometrics, Inc. | 2013-01-03 |
| K122816 | AXCESS SOFT TIP WIRE GUIDE | Wilson-Cook Medical, Inc. | 2012-10-09 |
| K113692 | XENX | Xenolith Medical | 2012-08-09 |
| K091417 | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | Terumo Corp. | 2009-05-22 |
| K082536 | COOK WIRE GUIDES | Cook Urological, Inc. | 2008-10-27 |
| K081708 | TAXI ENDOSCOPIC GUIDEWIRE | Lake Region Mfg., Inc. | 2008-08-26 |
| K080508 | MANDREL GUIDEWIRES OR M-WIRE | Lake Region Medical | 2008-03-21 |
| K072354 | GUIDEWIRE, MODEL G-V220-3527S AND OTHERS | Accellent, Inc. | 2007-12-07 |
| K060034 | NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE | Nipro Medical Corporation | 2006-02-28 |
| K053028 | TECHDEVICE GUIDEWIRE | Techdevice Corporation | 2006-01-31 |
| K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE | Conmedcorp | 2005-03-08 |
| K040137 | WILSON-COOK USW CAP AND WIRE LOCK | Wilson-Cook Medical, Inc. | 2004-02-20 |
| K033754 | TRACER METRO SMART WIRE GUIDE | Wilson-Cook Medical, Inc. | 2003-12-30 |
| K023603 | ENDO-GLIDE GUIDEWIRE | Endo-Therapeutics, Inc. | 2003-02-19 |
| K021179 | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002-07-05 |
| K011759 | RADIUS NEXT GENERATION GUIDEWIRE | Radius Medical Technologies, Inc. | 2001-08-23 |
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | Flexmedics | 1999-03-15 |
| K971937 | CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE | Terumo Medical Corp. | 1997-08-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729203070 | Wallstent | LAKE REGION MEDICAL LIMITED | 2016-11-06 |
| 08714729747291 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747529 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747482 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747475 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747468 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747451 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747437 | Jagtail | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747413 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747406 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747390 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747383 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747369 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747345 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747321 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747307 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747284 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747277 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747260 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747253 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747246 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747239 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747222 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747215 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747192 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747161 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747154 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729747130 | Jagwire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729746782 | Pathfinder | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729741404 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |