C-PTFETM Surgical Suture
FDA 510(k) K173922 · Cp Medical, Inc.
510(k) numberK173922
Submission
- Device name
- C-PTFETM Surgical Suture
- Applicant
- Cp Medical, Inc.
Norcross, GA, US - Received
- December 26, 2017
- Decision date
- March 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5035
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NBY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231277 | TissueStatNBY · Traditional | Durastat, LLC | 11/09/2023SE |
| K192088 | GOLNIT Non-aborbable PTFE Surgical SutureNBY · Special | Antarma, LLC Dba Golnit Sutures | 09/04/2019SE |
| K180992 | BiotexNBY · Abbreviated | Purgo Biologics, Inc. | 07/16/2019SE |
| K191317 | StitchKitNBY · Traditional | Origami Surgical | 07/12/2019SE |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical SutureNBY · Traditional | Demetech Corporation | 10/11/2018SE |
| K180630 | PTFE Surgical SutureNBY · Special | Omnia Spa | 04/06/2018SE |
| K173335 | Gazelle PTFE and Suture Delivery DeviceNBY · Abbreviated | Dura Tap, LLC | 02/08/2018SE |
| K170842 | Wego-PtfeNBY · Traditional | Foosin Medical Supplies Inc., Ltd. | 07/31/2017SE |
| K163049 | GOLNIT Non-Absorbable PTFE Surgical SutureNBY · Traditional | Antarma Dba Golnit Sutures | 06/21/2017SE |
| K163639 | LS-5 ePTFE SutureNBY · Traditional | Lsi Solutions | 06/02/2017SE |
More from Lsi Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K094028 | Cp-Fiber (Orthofiber)GAT · Abbreviated | 03/18/2010SE |
| K072229 | MonoswiftGAM · Abbreviated | 10/05/2007SE |
| K071550 | Pre-Waxed Needles with Gold Fiduciary MarkersKXK · Abbreviated | 07/18/2007SE |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31MTJ · Traditional | 11/02/2006SE |
| K041894 | OrthofiberGAT · Special | 09/17/2004SE |
| K034062 | CP Sleeve and River SleeveKXK · Special | 01/30/2004SE |
| K024372 | CP Medical Bone WaxMTJ · Traditional | 06/19/2003SE |
| K030786 | Mono-SwiftNEW · Abbreviated | 05/06/2003SE |
| K030351 | Stainless Steel Surgical Suture, Non-AbsorbableGAQ · Abbreviated | 03/28/2003SE |
| K023710 | Visorb SwiftGAM · Traditional | 01/17/2003SE |
Questions and answers
When was C-PTFETM Surgical Suture cleared by the FDA?
C-PTFETM Surgical Suture (K173922) received a 510(k) decision of Substantially Equivalent on March 26, 2018, 90 days after the submission was received.
What is the product code of K173922?
The FDA product code is NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5035.