K961295 is an FDA 510(k) clearance for the SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on June 26, 1996, 83 days after receiving the submission on April 4, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K961295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1996 |
| Decision Date | June 26, 1996 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |