K993689 is an FDA 510(k) clearance for the AED CYSTOSCOPE. This device is classified as a Cystoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAJ).
Submitted by National Advanced Endoscopy Devices, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 15, 1999, 44 days after receiving the submission on November 1, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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)..
| 510(k) Number | K993689 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 1999 |
| Decision Date | December 15, 1999 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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). |