Radifocus Glidewire Endoscopic Wire
FDA 510(k) K151471 · Terumo Medical Corporation
510(k) numberK151471
Submission
- Device name
- Radifocus Glidewire Endoscopic Wire
- Applicant
- Terumo Medical Corporation
Somerset, NJ, US - Received
- June 1, 2015
- Decision date
- September 17, 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153264 | EasyPass GuidewireOCY · Traditional | Medi-Globe Corporation | 05/19/2016SE |
| 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 |
| 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 |
More from Lake Region Medical
| 510(k) | Device | Decision |
|---|---|---|
| K231044 | R2P NavicrossDQY · Traditional | 07/27/2023SE |
| K213531 | TR BAND Radial Compression DeviceDXC · Traditional | 12/20/2021SE |
| K193125 | R2P Destination Slender Guiding SheathDYB · Traditional | 01/06/2020SE |
| K181237 | Glidesheath Slender Tibial Pedal KitDYB · Traditional | 08/03/2018SE |
| K173831 | Glidesheath SlenderDYB · Traditional | 05/08/2018SE |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…DYB · Traditional | 11/21/2017SE |
| K171491 | R2P Destination Slender Guiding SheathDYB · Traditional | 10/05/2017SE |
| K152173 | GlidesheathDYB · Traditional | 12/01/2015SE |
| K152525 | TR BAND Radial Compression DeviceDXC · Traditional | 11/10/2015SE |
| K142183 | Glidesheath SlenderDYB · Special | 11/21/2014SE |
Questions and answers
When was Radifocus Glidewire Endoscopic Wire cleared by the FDA?
Radifocus Glidewire Endoscopic Wire (K151471) received a 510(k) decision of Substantially Equivalent on September 17, 2015, 108 days after the submission was received.
What is the product code of K151471?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.