← Back to catalogue

Isolator® Linear Pen (MLP1) +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221358

by Atricure, Inc.

Identifiers

510(k) Number
K221358 FDA 510(k)
FDA Product Code
OCL FDA 510(k)
Models / Variants
Isolator® Linear Pen (MLP1) FDA 510(k)
Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1) FDA 510(k)
Isolator® Synergy Surgical Ablation System (EMR2, EML2) FDA 510(k)
Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System FDA 510(k)
Isolator® Synergy Access Clamp (EMT1) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Isolator® Linear Pen (MLP1) +4 more models by Atricure, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K221358 24 fields · synced Jun 18, 2026