K915725 is an FDA 510(k) clearance for the CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE, a Pneumoperitoneum Needle (Class II — Special Controls, product code FHO), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 16, 1992, 332 days after receiving the submission on December 20, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K915725 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1991 |
| Decision Date | November 16, 1992 |
| Days to Decision | 332 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FHO — Pneumoperitoneum Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | For Establishment Of A Pneumoperitoneum In Abdomen. |