Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic
FDA 510(k) K131072 · Coloplast A/S
510(k) numberK131072
Submission
- Device name
- Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- April 17, 2013
- Decision date
- July 9, 2013
- 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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|---|---|---|---|
| K153264 | EasyPass GuidewireOCY · Traditional | Medi-Globe Corporation | 05/19/2016SE |
| K151471 | Radifocus Glidewire Endoscopic WireOCY · Traditional | Terumo Medical Corporation | 09/17/2015SE |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | Coloplast A/S | 05/27/2015SE |
| 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 |
| K124052 | Ostavi Hydrophilic GuidewireOCY · Traditional | Lake Region Medical | 02/26/2013SE |
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Questions and answers
When was Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic cleared by the FDA?
Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic (K131072) received a 510(k) decision of Substantially Equivalent on July 9, 2013, 83 days after the submission was received.
What is the product code of K131072?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.