K934928 is an FDA 510(k) clearance for the INSITE FILTER & TUBING SET. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Andronic Devices, Ltd. (Richmond, B.C. Canada V6v 2j2, CA). The FDA issued a Cleared decision on May 26, 1994, 224 days after receiving the submission on October 14, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K934928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1993 |
| Decision Date | May 26, 1994 |
| Days to Decision | 224 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 |