K012556 is an FDA 510(k) clearance for the REPROCESSED GUIDEWIRES. This device is classified as a Catheter, Biliary, Reprocessed (Class II - Special Controls, product code NML).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 29, 2002, 264 days after receiving the submission on August 8, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010. Same As "fge" Except Being Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K012556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2001 |
| Decision Date | April 29, 2002 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NML — Catheter, Biliary, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |
| Definition | Same As "fge" Except Being Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |