Cleared Traditional

K911932 - J105 JAMES SURGICAL SYSTEM I/A PACK

K911932 is an FDA 510(k) clearance for J105 JAMES SURGICAL SYSTEM I/A PACK, manufactured by O.R. Specialties, Inc.. The device is a Class 1 Neurology device with product code GZX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

FDA 510(k) Submission Details - K911932

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.

GZX Device Classification - Class 1, General Controls

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.

Regulatory Peers - GZX Instrument, Microsurgical

All 10
Devices cleared under the same product code (GZX) and FDA review panel - the closest regulatory comparables to K911932.
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MICRA MICROSURGICAL INSTRUMENTS
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THE VICKERS STANDARD MICROSURGERY SET
K853161 · Keeler Instruments, Inc. · Nov 1985