K980238 is an FDA 510(k) clearance for the GYNEX EXTENDED REACH NEEDLE, a Set, Anesthesia, Paracervical (Class II — Special Controls, product code HEE), submitted by Gynex Corp. (Concord, US). The FDA issued a Cleared decision on August 21, 1998, 210 days after receiving the submission on January 23, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5100.
| 510(k) Number | K980238 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 1998 |
| Decision Date | August 21, 1998 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEE — Set, Anesthesia, Paracervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5100 |