Catalogue number SC-4317-01, listed by Boston Scientific Neuromodulation Corporation, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
Record
Regulatory record for Fixate™ Suturing Device | Listed by | Boston Scientific Neuromodulation Corporation, United States |
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-09-24 |
| Record revised | 2023-06-02 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.