Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999
FDA 510(k) K040232 · Lsi Solutions
510(k) numberK040232
Submission
- Device name
- Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999
- Applicant
- Lsi Solutions
Victor, NY, US - Received
- February 2, 2004
- Decision date
- March 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
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| 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 |
| 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 Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999 cleared by the FDA?
Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999 (K040232) received a 510(k) decision of Substantially Equivalent on March 1, 2004, 28 days after the submission was received.
What is the product code of K040232?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.