GUIDE WIRE
FDA 510(k) clearance K874164 · decided 1987-12-07
Clearance details
- K-number
- K874164
- Device name
- GUIDE WIRE
- Applicant
- Endovations
- Decision
- Substantially Equivalent
- Date received
- 1987-10-13
- Decision date
- 1987-12-07
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- EZB
- Device class
- 1
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Camp Hill, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (K971498) | Applied Medical Resources | 1997-05-05 |
| CORE AND COIL ASSEMBLY GUIDEWIRE (K970994) | Lake Region Mfg., Inc. | 1997-03-25 |
Recalls involving this device
No recalls on record reference this clearance.