FDA Product Code
FDA Product Code OCY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153264 | EasyPass Guidewire | Medi-Globe Corporation | 2016-05-19 | Traditional | PDF ↗ |
| K151471 | Radifocus Glidewire Endoscopic Wire | Terumo Medical Corporation | 2015-09-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015-03-16 | Traditional | PDF ↗ |
| K142950 | Acrobat Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | 2014-11-05 | Special | PDF ↗ |
| K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | Boston Scientific Corp | 2014-10-21 | Traditional | PDF ↗ |
| K142397 | Predicate III Guidewire | Lake Region Medical | 2014-09-19 | Special | PDF ↗ |
| K140482 | MANDREL GUIDEWIRE | Lake Region Medical | 2014-04-08 | Special | PDF ↗ |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | Neometrics, Inc. | 2014-02-20 | Traditional | PDF ↗ |
| K131072 | ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC | Coloplast A/S | 2013-07-09 | Traditional | PDF ↗ |
| K124052 | OSTAVI HYDROPHILIC GUIDEWIRE | Lake Region Medical | 2013-02-26 | Traditional | PDF ↗ |
| K123438 | XENX STONE MANAGEMENT DEVICE | Xenolith Medical | 2013-01-10 | Special | PDF ↗ |
| K123439 | NEO ERCP GUIDEWIRE | Neometrics, Inc. | 2013-01-03 | Traditional | PDF ↗ |
| K122816 | AXCESS SOFT TIP WIRE GUIDE | Wilson-Cook Medical, Inc. | 2012-10-09 | Special | PDF ↗ |
| K113692 | XENX | Xenolith Medical | 2012-08-09 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K082536 | COOK WIRE GUIDES | Cook Urological, Inc. | 2008-10-27 | Traditional | PDF ↗ |
| K081708 | TAXI ENDOSCOPIC GUIDEWIRE | Lake Region Mfg., Inc. | 2008-08-26 | Traditional | PDF ↗ |
| K080508 | MANDREL GUIDEWIRES OR M-WIRE | Lake Region Medical | 2008-03-21 | Special | PDF ↗ |
| K072354 | GUIDEWIRE, MODEL G-V220-3527S AND OTHERS | Accellent, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K060034 | NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE | Nipro Medical Corporation | 2006-02-28 | Traditional | PDF ↗ |
| K053028 | TECHDEVICE GUIDEWIRE | Techdevice Corporation | 2006-01-31 | Traditional | PDF ↗ |
| K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE | Conmedcorp | 2005-03-08 | Special | PDF ↗ |
| K040137 | WILSON-COOK USW CAP AND WIRE LOCK | Wilson-Cook Medical, Inc. | 2004-02-20 | Traditional | PDF ↗ |
| K033754 | TRACER METRO SMART WIRE GUIDE | Wilson-Cook Medical, Inc. | 2003-12-30 | Special | PDF ↗ |
| K023603 | ENDO-GLIDE GUIDEWIRE | Endo-Therapeutics, Inc. | 2003-02-19 | Traditional | PDF ↗ |
| K021179 | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002-07-05 | Traditional | PDF ↗ |
| K011759 | RADIUS NEXT GENERATION GUIDEWIRE | Radius Medical Technologies, Inc. | 2001-08-23 | Traditional | PDF ↗ |
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | Flexmedics | 1999-03-15 | Special | PDF ↗ |
| K971937 | CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE | Terumo Medical Corp. | 1997-08-15 | Traditional | PDF ↗ |
| K964780 | BARD DIRECTOR GUIDEWIRE (000560) | C.R. Bard, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K964955 | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING | Flexmedics | 1997-02-14 | Traditional | PDF ↗ |
| K962178 | BARD TIGER GUIDEWIRE MODEL 000540 | C.R. Bard, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K944959 | AMPLATZ SUPER STIFF GUIDEWIRE | Boston Scientific Corp | 1994-11-04 | Traditional | PDF ↗ |
| K943737 | MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE | Boston Scientific Corp | 1994-08-17 | Traditional | PDF ↗ |
| K933110 | OLYMPUS GUIDE WIRE | Olympus Corp. | 1993-11-04 | Traditional | PDF ↗ |
| K923755 | FLEX FINDER GUIDEWIRE | Flex Medics Corporation | 1993-09-03 | Traditional | PDF ↗ |
| K931650 | MICROVASIVE INSURG GEENEN CBD GUIDE WIRE | Boston Scientific Corp | 1993-06-25 | Traditional | PDF ↗ |
| K910497 | WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE | Wilson-Cook Medical, Inc. | 1991-04-02 | Traditional | PDF ↗ |
| K910722 | 450CM GUIDE WIRE FOR G.I. USE | Terumo Corp. | 1991-03-21 | Traditional | PDF ↗ |
| K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE | Telemed Systems, Inc. | 1990-06-05 | Traditional | PDF ↗ |
| K892648 | MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 | Boston Scientific Corp | 1989-05-24 | Traditional | PDF ↗ |
| K813026 | GUIDE WIRE | Inmed Corp. | 1981-11-17 | Traditional | PDF ↗ |
Product code OCY · Class II · Gastroenterology, Urology. Data: openFDA.