K912398 is an FDA 510(k) clearance for the ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 17, 1991, 207 days after receiving the submission on May 24, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K912398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1991 |
| Decision Date | December 17, 1991 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |