Cleared Traditional

K845035 - ELECTRODE FOR NEUROLOGICAL SURGERY 2111

K845035 is an FDA 510(k) clearance for ELECTRODE FOR NEUROLOGICAL SURGERY 2111, manufactured by Progress Mankind Technology. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K845035 · Progress Mankind Technology · Neurology device
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Jul 1985
Decision
215d
Days
Class 2
Risk

K845035 is an FDA 510(k) clearance for the ELECTRODE FOR NEUROLOGICAL SURGERY 2111. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Progress Mankind Technology (Hopkins, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 215 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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 Progress Mankind Technology devices

FDA 510(k) Submission Details - K845035

510(k) Number K845035 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 27, 1984
Decision Date July 30, 1985
Days to Decision 215 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
67d slower than avg
Panel avg: 148d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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.