510(k) K192615

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) by Synovis Life Technologies, Inc. (Baxter International Inc.) — Product Code FTM

K192615 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. (Baxter International Inc.) for the device "Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)". The FDA issued a decision of Substantially Equivalent on December 17, 2019. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2019
Date Received
September 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type