K820269 is an FDA 510(k) clearance for the RNG SERIES ULTRASOUND NEEDLE/CATH. GDS. This device is classified as a Needle, Biopsy, Cardiovascular (Class I - General Controls, product code DWO).
Submitted by CIVCO Medical Instruments Co., Inc. (Walker, US). The FDA issued a Cleared decision on March 23, 1982, 49 days after receiving the submission on February 2, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K820269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1982 |
| Decision Date | March 23, 1982 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | DWO — Needle, Biopsy, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |