K993951 is an FDA 510(k) clearance for the SPOT ENDOSCOPIC MARKER. This device is classified as a Marker, Colon (Class II - Special Controls, product code NBG).
Submitted by Chek-Med Systems (Willington, US). The FDA issued a Cleared decision on February 18, 2000, 88 days after receiving the submission on November 22, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K993951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1999 |
| Decision Date | February 18, 2000 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | NBG — Marker, Colon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |