← Back to catalogue
AtriCure Isolator Synergy EnCompass Clamp and Guide System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AtriCure Isolator Synergy EnCompass Clamp and Guide System FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide FDA UDI
- Model / Reference
- OSH FDA UDI
- Description
- Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide FDA UDI
Identifiers
- Catalog Number
- A001144 FDA UDI
- Primary DI / UDI-DI
- 10840143904127 FDA UDI
- 510(k) Number
- K210477 FDA UDI
- FDA Product Code
- OCL FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac radio-frequency ablation system generator
AtriCure Isolator Synergy EnCompass Clamp and Guide System by Atricure, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system generator.
- CARDIOBLATE® — MEDTRONIC, INC. · Class II
- ATAKR® II — MEDTRONIC, INC. · Class III
- INTELLAGEN™ Remote Control — Stockert GmbH · Class III
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC. · Class III
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
- nGEN Generator D138402 — Biosense Webster Inc · Class III
- Cardioblate™ — MEDTRONIC, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA UDI a668b6e1-6b9b-4f45-b285-2fffa80836b1 37 fields · synced Jun 1, 2026