K974138 is an FDA 510(k) clearance for the ROCKET ELECTRODE, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 30, 1998, 88 days after receiving the submission on November 3, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K974138 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 03, 1997 |
| Decision Date | January 30, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGI — Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4120 |