The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Spiral Pds Plus Bidirectional Knotless Tissue Control Device.
| Device ID | K192144 |
| 510k Number | K192144 |
| Device Name: | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Contact | Eleanor Zhou |
| Correspondent | Joice Pappan Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-08-08 |
| Decision Date | 2020-03-25 |