K760175 is an FDA 510(k) clearance for the DRAPE, TRANSURETHRAL RESECTION (TUR). This device is classified as a Drape, Pure Latex Sheet, With Self-retaining Finger Cot (Class II - Special Controls, product code EYX).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976, 55 days after receiving the submission on July 6, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K760175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1976 |
| Decision Date | August 30, 1976 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | EYX — Drape, Pure Latex Sheet, With Self-retaining Finger Cot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |