K963043 is an FDA 510(k) clearance for the ENDOSPOT. This device is classified as a Light Source, Fiberoptic, Routine (Class II - Special Controls, product code FCW).
Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on September 20, 1996, 46 days after receiving the submission on August 5, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K963043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1996 |
| Decision Date | September 20, 1996 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCW - Light Source, Fiberoptic, Routine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |