RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
FDA 510(k) K203081 · Lsi Solutions
510(k) numberK203081
Submission
- Device name
- RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
- Applicant
- Lsi Solutions
Victor, NY, US - Received
- October 13, 2020
- Decision date
- November 24, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAS – Suture, Nonabsorbable, Synthetic, Polyester
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…GAS · Special | Lsi Solutions, Inc. | 11/24/2020SE |
| K091018 | Arthrex BiowireGAS · Traditional | Arthrex, Inc. | 07/30/2010SE |
| K002261 | Mr-IiiGAS · Traditional | Smith & Nephew, Inc. | 10/23/2000SE |
| K953128 | Suture CordGAS · Traditional | Phoenix Biomedical Corp. | 02/09/1996SN |
| K923161 | Braided Polyester Suture MaterialGAS · Traditional | Mitek Surgical Products, Inc. | 12/30/1992SE |
| K913101 | Peters Cardioflon(Tm) SutureGAS · Traditional | Promedica Products, Inc. | 08/12/1992SE |
| K915089 | Mitek Quickanchor(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 02/03/1992SE |
| K915081 | Mitek Snap Pak(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 01/31/1992SE |
| K903175 | Advance Suture Nonabsorbable Dacron SutureGAS · Traditional | Advance Suture, Inc. | 07/26/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 02/11/1991SE |
More from Internacional Farmaceutica, S.A. DE C.V.
| 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 |
| 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 |
| 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 RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture cleared by the FDA?
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (K203081) received a 510(k) decision of Substantially Equivalent on November 24, 2020, 42 days after the submission was received.
What is the product code of K203081?
The FDA product code is GAS – Suture, Nonabsorbable, Synthetic, Polyester, a Class II (moderate risk) device regulated under 21 CFR 878.5000.