Company ยท US
Lsi Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2024. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 |
| HEW | Culdoscope (And Accessories) | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 1 |
| ODC | Endoscope Channel Accessory | 1 |
| SBK | Artificial Chordae Tendineae Surgical Replacement System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2024 | DEN230069 | Mi-CHORD System Lsi Solutions, Inc. | SBK |
| Jan 12, 2024 | K222783 | MD Mattress Suture Placement Device Lsi Solutions, Inc. | GCJ |
| Jun 24, 2021 | K202551 | Cor-Knot Micro Lsi Solutions, Inc. | GCJ |
| Nov 24, 2020 | K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene Lsi Solutions, Inc. | GAS |
| Nov 24, 2020 | K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture Lsi Solutions | GAS |
| Jun 2, 2017 | K163639 | LS-5 ePTFE Suture Lsi Solutions | NBY |
| Jul 13, 2012 | K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES Lsi Solutions, Inc. | HEW |
| Oct 13, 2010 | K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME Lsi Solutions, Inc. | GAW |
| Mar 1, 2004 | K040232 | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 Lsi Solutions | GAT |
| Jun 18, 2003 | K031443 | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS Lsi Solutions | NEW |
| Mar 24, 2003 | K024301 | LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT Lsi Solutions | ODC |
| Apr 27, 2001 | K011016 | LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT Lsi Solutions | GCJ |
| Jul 13, 1998 | K981531 | SUTURE PLACEMENT DEVICE AND ACCESSORIES Lsi Solutions | GCJ |
| Jan 8, 1997 | K963919 | LSI VIDEOSCOPIC DISPLAY SYSTEM Lsi Solutions | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||