K882647 is an FDA 510(k) clearance for the GESCO CATHETERIZATION TRAY. This device is classified as a Catheter, Continuous Irrigation (Class I - General Controls, product code GBQ).
Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on September 9, 1988, 74 days after receiving the submission on June 27, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K882647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | June 27, 1988 |
| Decision Date | September 09, 1988 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBQ — Catheter, Continuous Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |