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 |