The following data is part of a premarket notification filed by Gordian Surgical Ltd. with the FDA for Troclose1200, Troclose1200 Cannula.
| Device ID | K171494 |
| 510k Number | K171494 |
| Device Name: | TroClose1200, TroClose1200 Cannula |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Gordian Surgical Ltd. 17 Tchelet Street Misgav Business Park, IL 2017400 |
| Contact | Amir Schvartzer |
| Correspondent | Susan Alpert Dr. Susan Alpert 2425 L Street NW Apt 307 Washington, DC 20037 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-22 |
| Decision Date | 2017-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290017191014 | K171494 | 000 |
| 17290017191000 | K171494 | 000 |