K111441 is an FDA 510(k) clearance for the UNIMAX VERESS NEEDLE. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Unimax Medical Systems, Inc. (Taipei County, TW). The FDA issued a Cleared decision on August 19, 2011, 87 days after receiving the submission on May 24, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K111441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2011 |
| Decision Date | August 19, 2011 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF - Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |