K841362 is an FDA 510(k) clearance for the TIDAL DISTENSION IRRIGATION SET. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 2, 1984, 122 days after receiving the submission on April 2, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K841362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1984 |
| Decision Date | August 02, 1984 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |