The following data is part of a premarket notification filed by Safestich Medical, Llc with the FDA for Amid Stapler.
| Device ID | K120268 |
| 510k Number | K120268 |
| Device Name: | AMID STAPLER |
| Classification | Staple, Implantable |
| Applicant | SAFESTICH MEDICAL, LLC 4400 BISCAYNE BLVD. SUITE 670 Miami, FL 33137 |
| Contact | Alina Caraballo |
| Correspondent | Alina Caraballo SAFESTICH MEDICAL, LLC 4400 BISCAYNE BLVD. SUITE 670 Miami, FL 33137 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-02-10 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMID STAPLER 77760127 3846248 Dead/Cancelled |
SafeStitch Medical, Inc. 2009-06-15 |