Cleared Traditional

J105 JAMES SURGICAL SYSTEM I/A PACK (K911932) - FDA 510(k) Clearance

Class I Neurology device.

K911932 · O.R. Specialties, Inc. · Neurology device
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Aug 1991
Decision
118d
Days
Class 1
Risk

K911932 is an FDA 510(k) clearance for the J105 JAMES SURGICAL SYSTEM I/A PACK. Classified as Instrument, Microsurgical (product code GZX), Class I - General Controls.

Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4525 - 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 O.R. Specialties, Inc. devices

Submission Details

510(k) Number K911932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1991
Decision Date August 26, 1991
Days to Decision 118 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 148d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GZX Instrument, Microsurgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4525
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.