The following data is part of a premarket notification filed by Ndo Surgical, Inc. with the FDA for Plicator Gsx Suturing System, Plicator Gsx, Plicator Instrument, Plicator Gsx Suture Cartridge.
| Device ID | K073671 |
| 510k Number | K073671 |
| Device Name: | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield, MA 02048 |
| Contact | John J Vozella |
| Correspondent | John J Vozella NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield, MA 02048 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-27 |
| Decision Date | 2008-03-26 |
| Summary: | summary |