K051505 is an FDA 510(k) clearance for the SCB/STERIS OR-LIGHT INTERFACE BOX. This device is classified as a Light, Surgical, Accessories (Class II - Special Controls, product code FTA).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 11, 2005, 65 days after receiving the submission on June 7, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K051505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2005 |
| Decision Date | August 11, 2005 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |