K111955 is an FDA 510(k) clearance for the MEDLINE PNEUMOPERITONEUM NEEDLE. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 16, 2011, 128 days after receiving the submission on July 11, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K111955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2011 |
| Decision Date | November 16, 2011 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |