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
FDA 510(k) K150927 · Coloplast A/S
510(k) numberK150927
Submission
- Device name
- 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
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- April 6, 2015
- Decision date
- May 27, 2015
- 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.
Other 510(k)s with product code OCY
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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 |
| 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 |
| 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 Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff cleared by the FDA?
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 (K150927) received a 510(k) decision of Substantially Equivalent on May 27, 2015, 51 days after the submission was received.
What is the product code of K150927?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.