K925558 is an FDA 510(k) clearance for the INFILTUBE. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on March 4, 1994, 486 days after receiving the submission on November 3, 1992.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K925558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1992 |
| Decision Date | March 04, 1994 |
| Days to Decision | 486 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 |