K924135 is an FDA 510(k) clearance for the FLEXIBLE URETERONEPHROSOCOPE. This device is classified as a Accessories, Cleaning, For Endoscope (Class II - Special Controls, product code FEB).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on April 14, 1993, 239 days after receiving the submission on August 18, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 876.1500. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K924135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1992 |
| Decision Date | April 14, 1993 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FEB — Accessories, Cleaning, For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |