Lsi Solutions Suture Quick Load Products
FDA 510(k) K031443 · Lsi Solutions
510(k) numberK031443
Submission
- Device name
- Lsi Solutions Suture Quick Load Products
- Applicant
- Lsi Solutions
Victor, NY, US - Received
- May 6, 2003
- Decision date
- June 18, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEW – Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4840
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253879 | Monofix PdoNEW · Traditional | Samyang Holdings Corporation | 08/25/2026SE |
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | Teleflex Medical, LLC | 07/09/2026SE |
| K252171 | Barbed PDO SutureNEW · Traditional | Sutura Medical Technology, Inc. | 06/12/2026SE |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional | ETHICON, Inc. | 05/18/2026SE |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional | ETHICON, Inc. | 11/12/2025SE |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO)NEW · Traditional | Feeltech Co., Ltd. | 10/20/2025SE |
| K250107 | V-soft Line Barbed Surgical Suture (Various)NEW · Traditional | Feeltech Co., Ltd. | 10/15/2025SE |
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | M/s. Meril Endo Surgery Private Limited. | 09/23/2025SE |
| K250977 | Suture-TOOL SystemNEW · Special | Suturion AB | 04/28/2025SE |
| K242835 | Suture-TOOL SystemNEW · Traditional | Suturion AB | 01/22/2025SE |
More from Suturion AB
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K163639 | LS-5 ePTFE SutureNBY · Traditional | 06/02/2017SE |
| 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 |
| 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 Lsi Solutions Suture Quick Load Products cleared by the FDA?
Lsi Solutions Suture Quick Load Products (K031443) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 43 days after the submission was received.
What is the product code of K031443?
The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.