K943624 is an FDA 510(k) clearance for the ELMED PNEUMOPERITONEUM NEEDLES. This device is classified as a Pneumoperitoneum Needle (Class II - Special Controls, product code FHO).
Submitted by Henke-Sass, Wolf GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on August 10, 1994, 15 days after receiving the submission on July 26, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. For Establishment Of A Pneumoperitoneum In Abdomen..
| 510(k) Number | K943624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1994 |
| Decision Date | August 10, 1994 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |