The following data is part of a premarket notification filed by Usgi Medical with the FDA for G-cath Tissue Anchor Delivery Catheter, Models 205302, 205333.
| Device ID | K100251 |
| 510k Number | K100251 |
| Device Name: | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | USGI MEDICAL 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Contact | Mary L Mooney |
| Correspondent | Mary L Mooney USGI MEDICAL 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-28 |
| Decision Date | 2010-02-17 |
| Summary: | summary |