K162582 is an FDA 510(k) clearance for the HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Fisher & Paykel Healthcare (Auckland, NZ). The FDA issued a Cleared decision on June 23, 2017, 281 days after receiving the submission on September 15, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K162582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2016 |
| Decision Date | June 23, 2017 |
| Days to Decision | 281 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 |