K951961 is an FDA 510(k) clearance for the KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR. 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 August 1, 1995, 97 days after receiving the submission on April 26, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K951961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1995 |
| Decision Date | August 01, 1995 |
| Days to Decision | 97 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 |