LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999— 510(k) K040232
Substantially EquivalentLsi Solutions
FDA 510(k) clearance K040232 for LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999, Substantially Equivalent on 2004-03-01. Applicant: Lsi Solutions. Device class: 2.
Clearance details
- Applicant
- Lsi Solutions
- Product code
- Code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Victor, NY, US
Recent devices under product code GAT
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- K163639 — LS-5 ePTFE Suture
- K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
- K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
- K011016 — LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
Adverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
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.