Submission Details
| 510(k) Number | K991424 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 1999 |
| Decision Date | July 22, 1999 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
INSULSCAN INSULATION TESTING SYSTEM
Jul 1999
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K991424 is an FDA 510(k) clearance for the INSULSCAN INSULATION TESTING SYSTEM, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Medicor Corp. (Vernon Hills, US). The FDA issued a Cleared decision on July 22, 1999, 90 days after receiving the submission on April 23, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
Device Classification
| Product Code | HFG — Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |
Manufacturer
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