Acrobat Calibrated Tip Wire Guide
FDA 510(k) K142950 · Wilson-Cook Medical, Inc.
510(k) numberK142950
Submission
- Device name
- Acrobat Calibrated Tip Wire Guide
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- October 10, 2014
- Decision date
- November 5, 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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| K150225 | NovaGold High Performance GuidewireOCY · Traditional | Neometrics, Inc. | 03/16/2015SE |
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| K142397 | Predicate III GuidewireOCY · Special | Lake Region Medical | 09/19/2014SE |
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| K133076 | Novagold High Performance GuidewireOCY · Traditional | Neometrics, Inc. | 02/20/2014SE |
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| K124052 | Ostavi Hydrophilic GuidewireOCY · Traditional | Lake Region Medical | 02/26/2013SE |
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Questions and answers
When was Acrobat Calibrated Tip Wire Guide cleared by the FDA?
Acrobat Calibrated Tip Wire Guide (K142950) received a 510(k) decision of Substantially Equivalent on November 5, 2014, 26 days after the submission was received.
What is the product code of K142950?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.