K981859 is an FDA 510(k) clearance for the SURGIFLATOR-20 ECU. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by W.O.M. World of Medicine GmbH (Washington, US). The FDA issued a Cleared decision on June 26, 1998, 30 days after receiving the submission on May 27, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K981859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 1998 |
| Decision Date | June 26, 1998 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |