LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT— 510(k) K011016
Substantially EquivalentLsi Solutions
FDA 510(k) clearance K011016 for LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT, Substantially Equivalent on 2001-04-27. Applicant: Lsi Solutions. Device class: 2.
Clearance details
- Applicant
- Lsi Solutions
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Recent devices under product code GCJ
view all- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
- K261614 — LED LCD Monitor (OEV-271H)
- K261249 — Universal Seal (5-12 mm)
More 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
- K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
- K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.