K090070 is an FDA 510(k) clearance for the INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Invuity, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 22, 2009, 100 days after receiving the submission on January 12, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K090070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2009 |
| Decision Date | April 22, 2009 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FST - Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |