Cleared Traditional

K962035 - GE STERILE ARTHROGRAM TRAY

K962035 is an FDA 510(k) clearance for GE STERILE ARTHROGRAM TRAY, manufactured by GE Medical Systems. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K962035 · GE Medical Systems · General Hospital
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Jun 1996
Decision
32d
Days
Class 2
Risk

K962035 is an FDA 510(k) clearance for the GE STERILE ARTHROGRAM TRAY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by GE Medical Systems (Tarpon Springs, US). The FDA issued a Cleared decision on June 25, 1996 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K962035

510(k) Number K962035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1996
Decision Date June 25, 1996
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 534
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K962035.
NON-CORING NEEDLE
K961088 · Arrow Intl., Inc. · Jul 1996
PUNCTUR-GUARD WINGED SET
K961251 · Bio-Plexus, Inc. · Jun 1996
SHARPS-TAINER
K961878 · Winfield Industries · Jun 1996
RNS ARTHROGRAM TRAY
K962040 · Contour Fabricators of Florida, Inc. · Jun 1996
BEC SHROUDED PLASTIC CANNULA
K961328 · Biological & Environmental Control Laboratories · May 1996
PERRY SPECIALTIES DESIGNS NEEDLE GUARD
K932889 · Perry Specialties Design, Inc. · May 1996