K003965 is an FDA 510(k) clearance for the MRI SAFE INSTRUMENTS. This device is classified as a Cannula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEA).
Submitted by Aesculap, Inc. (Allentown, US). The FDA issued a Cleared decision on March 16, 2001, 84 days after receiving the submission on December 22, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K003965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2000 |
| Decision Date | March 16, 2001 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEA — Cannula, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |