SUTURE PLACEMENT DEVICE AND ACCESSORIES— 510(k) K981531
Substantially EquivalentLsi Solutions
FDA 510(k) clearance K981531 for SUTURE PLACEMENT DEVICE AND ACCESSORIES, Substantially Equivalent on 1998-07-13. Applicant: Lsi Solutions. Device class: 2.
Clearance details
- Applicant
- Lsi Solutions
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code GCJ
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
- 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.