K860357 is an FDA 510(k) clearance for the HGM, INC. LASERCATH (STERILE). This device is classified as a Laser For Gastro-urology Use (Class II - Special Controls, product code LNK).
Submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 7, 1986, 67 days after receiving the submission on January 30, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K860357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1986 |
| Decision Date | April 07, 1986 |
| Days to Decision | 67 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 |