K955073 is an FDA 510(k) clearance for the KSEA THERMOFLATOR (MODEL 26 4320 20). This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 6, 1996, 396 days after receiving the submission on November 6, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K955073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1995 |
| Decision Date | December 06, 1996 |
| Days to Decision | 396 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 |