The following data is part of a premarket notification filed by Gordian Surgical Ltd. with the FDA for Troclose1200.
| Device ID | K160564 |
| 510k Number | K160564 |
| Device Name: | TroClose1200 |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | GORDIAN SURGICAL LTD. 17TH TCHELET ST. Karmiel, IL 2161401 |
| Contact | Zvi Peer |
| Correspondent | Susan Alpert DR. SUSAN ALPERT 200 PARK AVENUE, UNIT 111 Minneapolis, MN 55415 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-11-17 |
| Summary: | summary |