Neo Ercp Guidewire
FDA 510(k) K123439 · Neometrics, Inc.
510(k) numberK123439
Submission
- Device name
- Neo Ercp Guidewire
- Applicant
- Neometrics, Inc.
Plymouth, MN, US - Received
- November 8, 2012
- Decision date
- January 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| K131072 | Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | Coloplast A/S | 07/09/2013SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K152560 | Bard Snare Retrieval KitMMX · Traditional | 10/23/2015SE |
| K150225 | NovaGold High Performance GuidewireOCY · Traditional | 03/16/2015SE |
| K143135 | Spring Coil GuidewireDQX · Traditional | 02/20/2015SE |
| K133076 | Novagold High Performance GuidewireOCY · Traditional | 02/20/2014SE |
| K101729 | Neowire Pta/Ptca GuidewireDQX · Traditional | 09/23/2010SE |
| K070150 | Vascupuncture Picc GuidewireDQX · Special | 02/15/2007SE |
| K043398 | Modification to Vascupuncture Picc GuidewireDQX · Special | 03/01/2005SE |
| K040786 | Vascupuncture Picc Guidewire with Hydro-Silk CoatingDQX · Special | 04/19/2004SE |
| K033321 | Selectiva SB GuidewireDQX · Special | 11/05/2003SE |
| K031652 | Vascupuncture Picc GuidewireDQX · Traditional | 09/30/2003SE |
Questions and answers
When was Neo Ercp Guidewire cleared by the FDA?
Neo Ercp Guidewire (K123439) received a 510(k) decision of Substantially Equivalent on January 3, 2013, 56 days after the submission was received.
What is the product code of K123439?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.