Product code NBY
- Device name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5035
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231277 | TissueStat | Durastat, LLC | 2023-11-09 |
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | 2019-09-04 |
| K180992 | Biotex | Purgo Biologics, Inc. | 2019-07-16 |
| K191317 | StitchKit | Origami Surgical | 2019-07-12 |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corporation | 2018-10-11 |
| K180630 | PTFE SURGICAL SUTURE | Omnia Spa | 2018-04-06 |
| K173922 | C-PTFETM Surgical Suture | Cp Medical, Inc. | 2018-03-26 |
| K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | 2018-02-08 |
| K170842 | WEGO-PTFE | Foosin Medical Supplies Inc., Ltd. | 2017-07-31 |
| K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | Antarma Dba Golnit Sutures | 2017-06-21 |
| K163639 | LS-5 ePTFE Suture | Lsi Solutions | 2017-06-02 |
| K160744 | LOOK PTFE Suture | Surgical Specialties Corporation | 2016-07-13 |
| K140415 | MONOTEX | Riverpoint Medical | 2014-03-26 |
| K132464 | PTFE SURGICAL SUTURE | Omnia Spa | 2014-02-12 |
| K123811 | STITCHKIT | Origami Surgical, LLC | 2013-09-05 |
| K072076 | CYTOPLAST PTFE SUTURE | Osteogenics Biomedical, Inc. | 2007-10-31 |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Osteogenics Biomedical, Inc. | 2000-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056646500864 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509454 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509430 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509416 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509393 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509379 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509355 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509331 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509317 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509294 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509270 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509256 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500963 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500857 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500871 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500888 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500895 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500901 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500918 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500925 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500932 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500949 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646500956 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 08056646509232 | Sterile PTFE Surgical Suture | OMNIA SRL | 2021-02-07 |
| 10304040001186 | Maxima | HENRY SCHEIN, INC. | 2016-08-04 |
| 10304040001193 | Maxima | HENRY SCHEIN, INC. | 2016-08-04 |
| 10304040001209 | Maxima | HENRY SCHEIN, INC. | 2016-08-04 |
| 10304040001216 | Maxima | HENRY SCHEIN, INC. | 2016-08-04 |
| 10304040001223 | Maxima | HENRY SCHEIN, INC. | 2016-08-04 |
| 10304040001230 | Maxima | HENRY SCHEIN, INC. | 2016-08-04 |