The following data is part of a premarket notification filed by Safepath Medical, Inc. with the FDA for Safepath Suturing System.
| Device ID | K180701 |
| 510k Number | K180701 |
| Device Name: | SafePath Suturing System |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | SafePath Medical, Inc. 21 Water Street - 5th Floor Amesbury, MA 01913 |
| Contact | Howard L. Schrayer |
| Correspondent | Howard L. Schrayer SafePath Medical, Inc. 21 Water Street - 5th Floor Amesbury, MA 01913 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-16 |
| Decision Date | 2018-06-25 |
| Summary: | summary |