Predicate III Guidewire
FDA 510(k) K142397 · Lake Region Medical
510(k) numberK142397
Submission
- Device name
- Predicate III Guidewire
- Applicant
- Lake Region Medical
Chaska, MN, US - Received
- August 27, 2014
- Decision date
- September 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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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| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | 03/19/2026SE |
| K242824 | PTFE GuidewireDQX · Special | 12/06/2024SE |
| K221575 | Pre-Formed BlueDQX · Traditional | 10/07/2022SE |
| K211741 | Pre-Formed Extra Support GuidewireDQX · Traditional | 11/22/2021SE |
| K160643 | ENROUTE 0.014 GuidewireDQX · Traditional | 10/18/2016SE |
| K151244 | Pre-Formed GuidewireDQX · Special | 06/11/2015SE |
| K140536 | Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T…DQX · Traditional | 12/17/2014SE |
| K142393 | Predicate III GuidewireDQX · Special | 11/25/2014SE |
| K140482 | Mandrel GuidewireOCY · Special | 04/08/2014SE |
| K133155 | Hydrophilic Coated GuidewireDQX · Traditional | 04/07/2014SE |
Questions and answers
When was Predicate III Guidewire cleared by the FDA?
Predicate III Guidewire (K142397) received a 510(k) decision of Substantially Equivalent on September 19, 2014, 23 days after the submission was received.
What is the product code of K142397?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.