The following data is part of a premarket notification filed by Restore Surgical Llc Dba Instratek with the FDA for Easyclip Xpress.
| Device ID | K162321 |
| 510k Number | K162321 |
| Device Name: | EasyClip Xpress |
| Classification | Staple, Fixation, Bone |
| Applicant | RESTORE SURGICAL LLC Dba Instratek 15200 Middlebrook Drive, Suite G Houston, TX 77058 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey RESTORE SURGICAL LLC Dba Instratek 15200 Middlebrook Drive, Suite G Houston, TX 77058 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-19 |
| Decision Date | 2017-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327358049 | K162321 | 000 |
| 07613327357912 | K162321 | 000 |
| 07613327357929 | K162321 | 000 |
| 07613327357936 | K162321 | 000 |
| 07613327357943 | K162321 | 000 |
| 07613327357950 | K162321 | 000 |
| 07613327357967 | K162321 | 000 |
| 07613327357974 | K162321 | 000 |
| 07613327357998 | K162321 | 000 |
| 07613327358001 | K162321 | 000 |
| 07613327358025 | K162321 | 000 |
| 07613327358032 | K162321 | 000 |
| 07613327357905 | K162321 | 000 |