K845021 is an FDA 510(k) clearance for the MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on May 20, 1985, 144 days after receiving the submission on December 27, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K845021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1984 |
| Decision Date | May 20, 1985 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |