K924103 is an FDA 510(k) clearance for the CLEANING BRUSH. This device is classified as a Accessories, Cleaning, For Endoscope (Class II - Special Controls, product code FEB).
Submitted by United States Endoscopy Group, Inc. (Waite Hill, US). The FDA issued a Cleared decision on November 16, 1992, 95 days after receiving the submission on August 13, 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 | K924103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1992 |
| Decision Date | November 16, 1992 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| 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). |