Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
FDA 510(k) K003028 · Osteogenics Biomedical, Inc.
510(k) numberK003028
Submission
- Device name
- Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
- Applicant
- Osteogenics Biomedical, Inc.
Lubbock, TX, US - Received
- September 28, 2000
- Decision date
- November 24, 2000
- 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
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|---|---|---|---|
| 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 |
| K173922 | C-PTFETM Surgical SutureNBY · Traditional | Cp Medical, Inc. | 03/26/2018SE |
| 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 |
More from Antarma Dba Golnit Sutures
| 510(k) | Device | Decision |
|---|---|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE MembranesNPK · Traditional | 01/23/2021SE |
| K171774 | RPM Reinforced PTFE MeshNPK · Traditional | 10/19/2017SE |
| K093719 | Pro-Fix Precision Fixation System Model Pfm#, Pfb#, Pft#DZL · Traditional | 03/01/2010SE |
| K072076 | Cytoplast PTFE SutureNBY · Abbreviated | 10/31/2007SE |
| K013764 | Immix Bone Graft ExtenderKKY · Traditional | 05/16/2002SE |
| K993610 | Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250LYC · Traditional | 03/02/2000SE |
| K984230 | Osteo-Mesh TM-300JEY · Traditional | 02/04/1999SE |
Questions and answers
When was Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC cleared by the FDA?
Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC (K003028) received a 510(k) decision of Substantially Equivalent on November 24, 2000, 57 days after the submission was received.
What is the product code of K003028?
The FDA product code is NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5035.