The following data is part of a premarket notification filed by Sutureease, Inc. with the FDA for Crossbow Fascial Closure System, Crossbow Fascial Closure System With Adaptor.
| Device ID | K172666 |
| 510k Number | K172666 |
| Device Name: | CrossBow Fascial Closure System, CrossBow Fascial Closure System With Adaptor |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | SutureEase, Inc. 1735 N First Street, Suite 300 San Jose, CA 95112 |
| Contact | Scott Heneveld |
| Correspondent | Scott Heneveld SutureEase, Inc. 1735 N First Street, Suite 300 San Jose, CA 95112 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-12-01 |
| Summary: | summary |