Cook Wire Guides
FDA 510(k) K082536 · Cook Urological, Inc.
510(k) numberK082536
Submission
- Device name
- Cook Wire Guides
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- September 2, 2008
- Decision date
- October 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCY – Endoscopic Guidewire, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
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| K150225 | NovaGold High Performance GuidewireOCY · Traditional | Neometrics, Inc. | 03/16/2015SE |
| K142950 | Acrobat Calibrated Tip Wire GuideOCY · Special | Wilson-Cook Medical, Inc. | 11/05/2014SE |
| K141820 | Jagwire High Performance GuidwireOCY · Traditional | Boston Scientific Corp | 10/21/2014SE |
| K142397 | Predicate III GuidewireOCY · Special | Lake Region Medical | 09/19/2014SE |
| K140482 | Mandrel GuidewireOCY · Special | Lake Region Medical | 04/08/2014SE |
| K133076 | Novagold High Performance GuidewireOCY · Traditional | Neometrics, Inc. | 02/20/2014SE |
| K131072 | Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | Coloplast A/S | 07/09/2013SE |
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| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
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| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
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Questions and answers
When was Cook Wire Guides cleared by the FDA?
Cook Wire Guides (K082536) received a 510(k) decision of Substantially Equivalent on October 27, 2008, 55 days after the submission was received.
What is the product code of K082536?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.