K933094 is an FDA 510(k) clearance for the INSUFFLATOR TUBING KIT W/FILTER. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on April 18, 1994, 298 days after receiving the submission on June 24, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K933094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1993 |
| Decision Date | April 18, 1994 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |