Cleared Traditional

K101592 - ERASE HAND- HELD CONTROLLER

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

K101592 is an FDA 510(k) clearance for ERASE HAND- HELD CONTROLLER, manufactured by Cheng Medical, Corporation. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K101592 · Cheng Medical, Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K101592

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
337d slower than avg
Panel avg: 149d · This submission: 486d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

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.
Polaris RF Ablation System
K181864 · Baylis Medical Company, Inc. · Jan 2019
Relievant Medsystems RF Generator
K171143 · Relievant Medsystems · Aug 2017
MultiGen™ 2 RF Generator System
K170242 · Stryker Corporation · May 2017
NT 2000 LESIONING GENERATOR
K111576 · Neuro Therm, Inc. · Sep 2011
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
K093185 · Diros Technology, Inc. · Jan 2010
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
K082051 · Cosman Medical, Inc. · Oct 2008
K101592 · ERASE HAND- HELD CONTROLLER
Download PDF FDA Summary Cheng Medical, Corpor…