K954774 is an FDA 510(k) clearance for the SHIELDED TROCAR (OBTURATOR). This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Gabris Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on June 7, 1996, 234 days after receiving the submission on October 17, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K954774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1995 |
| Decision Date | June 07, 1996 |
| Days to Decision | 234 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 |