MANTIS Clip— 510(k) K221124

Name: FDA 510(k) clearance K221124
Creator: U.S. Food and Drug Administration
Published: 2022-08-04

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K221124 for MANTIS Clip, Substantially Equivalent on 2022-08-04. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2022-04-18
Decision date: 2022-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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K253734 — Taurus Clip2026-03-12
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18

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Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.