The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Suturetape.
| Device ID | K171296 |
| 510k Number | K171296 |
| Device Name: | SutureTape |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Ivette Galmez |
| Correspondent | Ivette Galmez Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-02 |
| Decision Date | 2017-05-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUTURETAPE 87768599 not registered Dead/Abandoned |
RIVERPOINT LLC 2018-01-24 |
![]() SUTURETAPE 86244208 not registered Dead/Abandoned |
Riverpoint LLC 2014-04-07 |