K012685 is an FDA 510(k) clearance for the REPROCESSED ENDOSCOPIC ELECTRODES. This device is classified as a Electrode, Electrosurgical, Active, Urological, Reprocessed (Class II - Special Controls, product code NLW).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 14, 2002, 184 days after receiving the submission on August 14, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300. The "electrode, Electrosurgical, Active, Urological, Reprocessed" Is Intended To Be Used Endoscopically To Contact Urologic Tissue So As To Allow Cutting, Coagulation, Electrodesiccation, Or Cautery Dessication By Means Of Electric Current. This Device Is Indicated For Reuse/reprocessing. 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) 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 | K012685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2001 |
| Decision Date | February 14, 2002 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NLW — Electrode, Electrosurgical, Active, Urological, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |
| Definition | The "electrode, Electrosurgical, Active, Urological, Reprocessed" Is Intended To Be Used Endoscopically To Contact Urologic Tissue So As To Allow Cutting, Coagulation, Electrodesiccation, Or Cautery Dessication By Means Of Electric Current. This Device Is Indicated For Reuse/reprocessing. 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) 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) |