APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
FDA 510(k) clearance K971498 · decided 1997-05-05
Clearance details
- K-number
- K971498
- Device name
- APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
- Applicant
- Applied Medical Resources
- Decision
- Substantially Equivalent
- Date received
- 1997-04-25
- Decision date
- 1997-05-05
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- EZB
- Device class
- 1
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Launa Hills, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Applied Medical Resources
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CORE AND COIL ASSEMBLY GUIDEWIRE (K970994) | Lake Region Mfg., Inc. | 1997-03-25 |
| GUIDE WIRE (K874164) | Endovations | 1987-12-07 |
Recalls involving this device
No recalls on record reference this clearance.