K874976 is an FDA 510(k) clearance for the PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME. This device is classified as a Cystotome (Class I - General Controls, product code HNY).
Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 13, 1988, 133 days after receiving the submission on December 2, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K874976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1987 |
| Decision Date | April 13, 1988 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNY — Cystotome |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |