K901413 is an FDA 510(k) clearance for the CORE DISPOSABLE INSUFFLATION TUBING. This device is classified as a Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (Class II - Special Controls, product code HES).
Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 24, 1990, 182 days after receiving the submission on March 26, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1300.
| 510(k) Number | K901413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1990 |
| Decision Date | September 24, 1990 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HES — Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1300 |