The following data is part of a premarket notification filed by Usgi Medical with the FDA for G-cinch Suture Grasper.
| Device ID | K102931 |
| 510k Number | K102931 |
| Device Name: | G-CINCH SUTURE GRASPER |
| Classification | Endoscopic Tissue Approximation Device |
| 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 | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2010-12-30 |
| Summary: | summary |