Lsi Solutions Flexible Suture Placement Device and Accessories Product
FDA 510(k) K011016 · Lsi Solutions
510(k) numberK011016
Submission
- Device name
- Lsi Solutions Flexible Suture Placement Device and Accessories Product
- Applicant
- Lsi Solutions
Rochester, NY, US - Received
- April 4, 2001
- Decision date
- April 27, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 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 |
| K031443 | Lsi Solutions Suture Quick Load ProductsNEW · Abbreviated | 06/18/2003SE |
| K024301 | Lsi Endoscopic External Accessory Channel and Accessories ProductODC · Traditional | 03/24/2003SE |
Questions and answers
When was Lsi Solutions Flexible Suture Placement Device and Accessories Product cleared by the FDA?
Lsi Solutions Flexible Suture Placement Device and Accessories Product (K011016) received a 510(k) decision of Substantially Equivalent on April 27, 2001, 23 days after the submission was received.
What is the product code of K011016?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.