K945789 is an FDA 510(k) clearance for the DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on February 7, 1995, 74 days after receiving the submission on November 25, 1994.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K945789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 74 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 |