K141781 is an FDA 510(k) clearance for the KOGENT SPETZLER LIGHTED SUCTION TUBES. This device is classified as a Illuminator, Fiberoptic, Surgical Field (Class II - Special Controls, product code HBI).
Submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on April 9, 2015, 281 days after receiving the submission on July 2, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K141781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2014 |
| Decision Date | April 09, 2015 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HBI - Illuminator, Fiberoptic, Surgical Field |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |