K930568 is an FDA 510(k) clearance for the ADAIR/VERESS NEEDLE INTRODUCER SET. This device is classified as a Needle, Catheter (Class I - General Controls, product code GCB).
Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on July 22, 1993, 177 days after receiving the submission on January 26, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K930568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1993 |
| Decision Date | July 22, 1993 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCB — Needle, Catheter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |