Chrysalis Intelligence · Product Codes · OCL

OCL · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

General, Plastic Surgery · 7 clearances · 2 unique sponsors

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Device class

Class II

Regulation 878.4400

Total clearances

2020-06-03 → 2025-07-24

Last 12 months

Unique sponsors

Definition

What is Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4400

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
AtriCure, Inc.	5	0	2025-07-24
Medtronic, Inc.	2	0	2022-12-22

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
15788	CPT	—	Medium	Ablation/amputation using electric cautery; cutting/coagulation/ablation surgical tool
93650	CPT	—	Medium	Intracardiac electrophysiology mapping and ablation if cardiac tissue is target

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-07-24	K252056	AtriCure, Inc.	Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
2024-08-27	K234151	AtriCure, Inc.	Isolator Synergy EnCapture Ablation System (EMH)
2022-12-30	K221358	AtriCure, Inc.	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)
2022-12-22	K223508	Medtronic, Inc.	Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
2021-07-26	K210477	AtriCure, Inc.	AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
2021-05-28	K211311	AtriCure, Inc.	AtriCure Isolator® Synergy Surgical Ablation System
2020-06-03	K200514	Medtronic	Cardioblate Gemini-s Surgical Ablation Device