K120151 is an FDA 510(k) clearance for the NEBULAE I. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on August 17, 2012, 212 days after receiving the submission on January 18, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K120151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2012 |
| Decision Date | August 17, 2012 |
| Days to Decision | 212 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 |