K874255 is an FDA 510(k) clearance for the ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.. This device is classified as a Laser For Gastro-urology Use (Class II - Special Controls, product code LNK).
Submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on July 12, 1988, 266 days after receiving the submission on October 20, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K874255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1987 |
| Decision Date | July 12, 1988 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LNK — Laser For Gastro-urology Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |