Cleared Traditional

ERASE HAND- HELD CONTROLLER (K101592) - FDA 510(k) Clearance

Also marketed or referenced as:
ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101592 · Cheng Medical, Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
486d
Days
Class 2
Risk

K101592 is an FDA 510(k) clearance for the ERASE HAND- HELD CONTROLLER. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Cheng Medical, Corporation (Saratoga, US). The FDA issued a Cleared decision on October 6, 2011 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Cheng Medical, Corporation devices

Submission Details

510(k) Number K101592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2010
Decision Date October 06, 2011
Days to Decision 486 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 148d · This submission: 486d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 Neurology devices follow this clearance model.

Regulatory Peers - GXD Generator, Lesion, Radiofrequency

All 36
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K101592.
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · Boston Scientific Neuromodulation Corporation · Aug 2025
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · Avanos Medical, Inc. · Aug 2024
Racz Neurostat RF Generator
K232632 · Epimed International · May 2024
OneRF Ablation System
K231675 · Neuroone Medical Technologies Corp. · Dec 2023
APEX 6
K220122 · Rf Innovations, Inc. · Mar 2023
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293 · Abbott Medical · Jan 2022