K892070 is an FDA 510(k) clearance for the GENERAL IVT NEEDLE GUIDE KIT, STERILE. This device is classified as a Transducer, Ultrasonic, Obstetric (Class II - Special Controls, product code HGL).
Submitted by Amedic USA (Sweden, SE). The FDA issued a Cleared decision on September 5, 1989, 158 days after receiving the submission on March 31, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2960.
| 510(k) Number | K892070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1989 |
| Decision Date | September 05, 1989 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HGL — Transducer, Ultrasonic, Obstetric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2960 |