K212458 is an FDA 510(k) clearance for the Flexible Video-Uretero-Renoscope SSU System. This device is classified as a Ureteroscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FGB).
Submitted by Karl Storz Endoscopy America (Los Angeles, US). The FDA issued a Cleared decision on January 20, 2022, 168 days after receiving the submission on August 5, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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 | K212458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2021 |
| Decision Date | January 20, 2022 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGB — Ureteroscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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). |