INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER— 510(k) K950277

Substantially Equivalent

Boston 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.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-23
Decision date: 1995-03-29
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, 2020-01-01 through 2026-04-23. 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.