Cleared Traditional

K192715 - CRF Radiofrequency Ablation System

K192715 is an FDA 510(k) clearance for CRF Radiofrequency Ablation System, manufactured by Cambridge Interventional, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K192715 · Cambridge Interventional, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
102d
Days
Class 2
Risk

K192715 is an FDA 510(k) clearance for the CRF Radiofrequency Ablation System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Cambridge Interventional, LLC (Burlington, US). The FDA issued a Cleared decision on January 7, 2020 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cambridge Interventional, LLC devices

FDA 510(k) Submission Details - K192715

510(k) Number K192715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date January 07, 2020
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1258
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K192715.
OKLand Patient Return Electrode Pad
K183148 · Auckland Medical Polymer(Tianjin) Co., Ltd. · Feb 2020
Viveve 2.0 System
K193611 · Viveve Medical, Inc. · Jan 2020
INTRAcel RF Microneedle System
K183284 · Jeisys Medical, Inc. · Jan 2020
InMode System with the Morpheus8 (Fractora) Applicators
K192695 · Inmode MD , Ltd. · Dec 2019
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
K191234 · Erbe Elektromedizin GmbH · Dec 2019
WEREWOLF COBLATION System, COBLATION HALO Wand
K192027 · ArthroCare Corporation · Dec 2019