K971498 is an FDA 510(k) clearance for the APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE. This device is classified as a Stylet For Catheter, Gastro-urology (Class I - General Controls, product code EZB).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on May 5, 1997, 10 days after receiving the submission on April 25, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K971498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1997 |
| Decision Date | May 05, 1997 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZB — Stylet For Catheter, Gastro-urology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5130 |