K051860 is an FDA 510(k) clearance for the FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837. This device is classified as a Needle, Spinal, Short Term (Class II - Special Controls, product code MIA).
Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 22, 2005, 45 days after receiving the submission on July 8, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K051860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2005 |
| Decision Date | August 22, 2005 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MIA - Needle, Spinal, Short Term |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5150 |