K911479 is an FDA 510(k) clearance for the LAPAROSCOPIC INSUFLATION Y TUBING. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on April 29, 1991, 25 days after receiving the submission on April 4, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K911479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1991 |
| Decision Date | April 29, 1991 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HIF - Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |