OPEN FMSEALER— 510(k) K141484

Name: FDA 510(k) clearance K141484
Creator: U.S. Food and Drug Administration
Published: 2014-07-30

Substantially Equivalent

Domain Surgical, Inc.

FDA 510(k) clearance K141484 for OPEN FMSEALER, Substantially Equivalent on 2014-07-30. Applicant: Domain Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Domain Surgical, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2014-06-05
Decision date: 2014-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Domain Surgical, Inc.

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K142229 — Laparoscopic FMsealer2015-01-02
K140384 — FMWAND HANDPIECE SE2014-05-23
K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM2014-01-03
K121881 — DOMAIN SURGICAL SYSTEM2012-10-18
K110439 — DOMAIN SURGICAL SYSTEM2011-07-18

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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 →

Recalls naming K141484

K-number listed on FDA's recall record

Z-0690-2017 — FMsealer Open Shears. Model FM3001Class II·Terminated·Domain Surgical, Inc.·20161024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141484.

Data sourced from openFDA. This site is unofficial and independent of the FDA.