K982565 is an FDA 510(k) clearance for the EASY TRANS TIP. This device is classified as a Monitor, Pressure, Intrauterine (Class II - Special Controls, product code KXO).
Submitted by Carl Schuh (Chatsowrth, US). The FDA issued a Cleared decision on September 22, 1998, 61 days after receiving the submission on July 23, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K982565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1998 |
| Decision Date | September 22, 1998 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KXO — Monitor, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |