K913267 is an FDA 510(k) clearance for the R-GROUP INTL. ONE WALL PUNCTURE NEEDLE. This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on June 5, 1992, 318 days after receiving the submission on July 23, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K913267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1991 |
| Decision Date | June 05, 1992 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |