INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER— 510(k) K950277
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K950277 for INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER, Substantially Equivalent on 1995-03-29. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- 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
- Traditional
- Location
- Watertown, MA, US
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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.