K760745 is an FDA 510(k) clearance for the YASARGIL SUCTION TUBE - SMALL. This device is classified as a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I - General Controls, product code GCY).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1976, 32 days after receiving the submission on September 30, 1976.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K760745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1976 |
| Decision Date | November 01, 1976 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4680 |