K231118 is an FDA 510(k) clearance for the Cystoscope System, a Cystoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAJ), submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 13, 2023, 207 days after receiving the submission on April 20, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K231118 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 2023 |
| Decision Date | November 13, 2023 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAJ — Cystoscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform 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). |