K973432 is an FDA 510(k) clearance for the SURGIFLATOR-30. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on December 9, 1997, 90 days after receiving the submission on September 10, 1997.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K973432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1997 |
| Decision Date | December 09, 1997 |
| Days to Decision | 90 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 |