The following data is part of a premarket notification filed by Safestitch Llc with the FDA for Amid Stapler.
| Device ID | K093253 |
| 510k Number | K093253 |
| Device Name: | AMID STAPLER |
| Classification | Staple, Implantable |
| Applicant | SAFESTITCH LLC 8282 SHADOW WOOD BLVD Coral Springs, FL 33071 |
| Contact | Stewart Davis |
| Correspondent | Stewart Davis SAFESTITCH LLC 8282 SHADOW WOOD BLVD Coral Springs, FL 33071 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-16 |
| Decision Date | 2009-11-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMID STAPLER 77760127 3846248 Dead/Cancelled |
SafeStitch Medical, Inc. 2009-06-15 |