FDA 510(k) Applications for Medical Device Product Code "NBY"
|
FDA 510(k) Number | Applicant | Device Name | Decision Date |
K163049 | Antarma dba Golnit Sutures | GOLNIT Non-Absorbable PTFE Surgical Suture | 06/21/2017 |
K192088 | Antarma LLC dba Golnit Sutures | GOLNIT Non-aborbable PTFE Surgical Suture | 09/04/2019 |
K173922 | CP Medical Inc. | C-PTFETM Surgical Suture | 03/26/2018 |
K181578 | Demetech Corporation | DemeTECH PTFE Nonabsorbable Surgical Suture | 10/11/2018 |
K173335 | Dura Tap LLC | Gazelle PTFE and Suture Delivery Device | 02/08/2018 |
K170842 | Foosin Medical Supplies Inc., Ltd. | WEGO-PTFE | 07/31/2017 |
K163639 | LSI SOLUTIONS | LS-5 ePTFE Suture | 06/02/2017 |
K180630 | OMNIA SPA | PTFE SURGICAL SUTURE | 04/06/2018 |
K132464 | OMNIA SPA | PTFE SURGICAL SUTURE | 02/12/2014 |
K191317 | Origami Surgical | StitchKit | 07/12/2019 |
K123811 | ORIGAMI SURGICAL LLC | STITCHKIT | 09/05/2013 |
K072076 | OSTEOGENICS BIOMEDICAL, INC. | CYTOPLAST PTFE SUTURE | 10/31/2007 |
K003028 | OSTEOGENICS BIOMEDICAL, INC. | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | 11/24/2000 |
K180992 | Purgo Biologics Inc. | Biotex | 07/16/2019 |
K140415 | RIVERPOINT MEDICAL | MONOTEX | 03/26/2014 |
K160744 | Surgical Specialties Corporation | LOOK PTFE Suture | 07/13/2016 |