LS-5 ePTFE Suture
FDA 510(k) K163639 · Lsi Solutions
510(k) numberK163639
Submission
- Device name
- LS-5 ePTFE Suture
- Applicant
- Lsi Solutions
Victor, NY, US - Received
- December 23, 2016
- Decision date
- June 2, 2017
- 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 |
| 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 |
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| K222783 | MD Mattress Suture Placement DeviceGCJ · Traditional | 01/12/2024SE |
| K202551 | Cor-Knot MicroGCJ · Traditional | 06/24/2021SE |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…GAS · Special | 11/24/2020SE |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureGAS · Special | 11/24/2020SE |
| K111014 | Lsi Solutions Fornisee System Uterine Manipulator and AccessoriesHEW · Traditional | 07/13/2012SE |
| K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and…GAW · Traditional | 10/13/2010SE |
| K040232 | Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model…GAT · Special | 03/01/2004SE |
| K031443 | Lsi Solutions Suture Quick Load ProductsNEW · Abbreviated | 06/18/2003SE |
| K024301 | Lsi Endoscopic External Accessory Channel and Accessories ProductODC · Traditional | 03/24/2003SE |
| K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories ProductGCJ · Special | 04/27/2001SE |
Questions and answers
When was LS-5 ePTFE Suture cleared by the FDA?
LS-5 ePTFE Suture (K163639) received a 510(k) decision of Substantially Equivalent on June 2, 2017, 161 days after the submission was received.
What is the product code of K163639?
The FDA product code is NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5035.