Endo-Glide Guidewire
FDA 510(k) K023603 · Endo-Therapeutics, Inc.
510(k) numberK023603
Submission
- Device name
- Endo-Glide Guidewire
- Applicant
- Endo-Therapeutics, Inc.
Safety Harbor, FL, US - Received
- October 28, 2002
- Decision date
- February 19, 2003
- 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.
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| K131072 | Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | Coloplast A/S | 07/09/2013SE |
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Questions and answers
When was Endo-Glide Guidewire cleared by the FDA?
Endo-Glide Guidewire (K023603) received a 510(k) decision of Substantially Equivalent on February 19, 2003, 114 days after the submission was received.
What is the product code of K023603?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.