Resectr Tissue Resection Device— 510(k) K191538

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K191538 for Resectr Tissue Resection Device, Substantially Equivalent on 2020-01-16. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2019-06-10
Decision date: 2020-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.