LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS— 510(k) K031443
Substantially EquivalentLsi Solutions
FDA 510(k) clearance K031443 for LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS, Substantially Equivalent on 2003-06-18. Applicant: Lsi Solutions. Device class: 2.
Clearance details
- Applicant
- Lsi Solutions
- Product code
- Product code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Victor, NY, US
Recent devices under product code NEW
view allMore clearances from Lsi Solutions
view all- K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
- K163639 — LS-5 ePTFE Suture
- K040232 — LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
- K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
- K011016 — LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
Adverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.