Cleared Traditional

K854334 - PAINBLOCKER WA5000

K854334 is an FDA 510(k) clearance for PAINBLOCKER WA5000, manufactured by Wallach Surgical Devices, Inc.. The device is a Class 2 Neurology device with product code GXH cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K854334 · Wallach Surgical Devices, Inc. · Neurology device
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Apr 1986
Decision
184d
Days
Class 2
Risk

K854334 is an FDA 510(k) clearance for the PAINBLOCKER WA5000. Classified as Device, Surgical, Cryogenic (product code GXH), Class II - Special Controls.

Submitted by Wallach Surgical Devices, Inc. (Milford, US). The FDA issued a Cleared decision on April 30, 1986 after a review of 184 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wallach Surgical Devices, Inc. devices

FDA 510(k) Submission Details - K854334

510(k) Number K854334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date April 30, 1986
Days to Decision 184 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 148d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXH Device Classification - Class 2, Special Controls

Product Code GXH Device, Surgical, Cryogenic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4250
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 - GXH Device, Surgical, Cryogenic

All 20
Devices cleared under the same product code (GXH) and FDA review panel - the closest regulatory comparables to K854334.
CRYO-TOUCH III
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MYOSCIENCE CRYO-TOUCH
K100447 · Myoscience, Inc. · Jun 2010
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272 · Cryomedical Instruments, Ltd. · Mar 2005
CRYOMEDICS NEUROSTAT
K831963 · Spembly Medical , Ltd. · Aug 1983
NEUROSTAT, LLOYD
K781302 · Spembly Medical , Ltd. · Aug 1978