The following data is part of a premarket notification filed by Usgi Medical with the FDA for G-lix Tissue Grasper.
| Device ID | K061268 |
| 510k Number | K061268 |
| Device Name: | G-LIX TISSUE GRASPER |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | USGI MEDICAL 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Contact | Mary Lou Mooney |
| Correspondent | Mary Lou Mooney USGI MEDICAL 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-05 |
| Decision Date | 2006-07-31 |
| Summary: | summary |