K833377 is an FDA 510(k) clearance for the MEDICALEX. This device is classified as a Cannula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEA).
Submitted by Medicalex (Walker, US). The FDA issued a Cleared decision on September 27, 1984, 364 days after receiving the submission on September 29, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K833377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1983 |
| Decision Date | September 27, 1984 |
| Days to Decision | 364 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEA — Cannula, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |