K834171 is an FDA 510(k) clearance for the OP-CON SURG. INSTRUMENT #3. This device is classified as a Surgical Instruments, G-u, Manual (and Accessories) (Class I - General Controls, product code KOA).
Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984, 135 days after receiving the submission on November 21, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K834171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1983 |
| Decision Date | April 04, 1984 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOA — Surgical Instruments, G-u, Manual (and Accessories) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |