K810018 is an FDA 510(k) clearance for the SURG-FLEX 5 SURGICAL LIGHT. This device is classified as a Light, Surgical, Instrument (Class II - Special Controls, product code FSQ).
Submitted by Medical Products Development, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1981, 18 days after receiving the submission on January 5, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K810018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1981 |
| Decision Date | January 23, 1981 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSQ — Light, Surgical, Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |