K010053 is an FDA 510(k) clearance for the HUMI-FLOW, MODEL 6-850-00/ 01/02. 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 October 23, 2001, 288 days after receiving the submission on January 8, 2001.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K010053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2001 |
| Decision Date | October 23, 2001 |
| Days to Decision | 288 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 |