Isolator® Linear Pen (MLP1) +4 more— 510(k) K221358
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K221358 for Isolator® Linear Pen (MLP1) +4 more, Substantially Equivalent on 2022-12-30. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
- Applicant
- AtriCure, Inc.
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason, OH, US
Recent devices under product code OCL
view all- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
- K211311 — AtriCure Isolator® Synergy Surgical Ablation System
More clearances from AtriCure, Inc.
view allAdverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
Source: openFDA MAUDE database, through . 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.