Stylet For Catheter, Gastro-Urology
The Stylet for Gastro-Urology Catheter (product code EZB) is a rigid internal guide wire used to stiffen or direct urological or gastrointestinal catheters during insertion. It is an FDA Class 1 device (lowest risk), subject to general controls only, with no premarket notification required. It is regulated under 21 CFR 876.5130 within the Gastroenterology and Urology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- EZB
- Device Class
- FDA class 1
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971498 | APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE | May 05, 1997 | Substantially Equivalent | Applied Medical Resources |
| K970994 | CORE AND COIL ASSEMBLY GUIDEWIRE | Mar 25, 1997 | Substantially Equivalent | Lake Region Mfg., Inc. |
| K874164 | GUIDE WIRE | Dec 07, 1987 | Substantially Equivalent | Endovations |
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.