Cleared Traditional

K834436 - CHEMONUCLEOLYSIS NEEDLE

K834436 is an FDA 510(k) clearance for CHEMONUCLEOLYSIS NEEDLE, manufactured by Universal Medical Instrument Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K834436 · Universal Medical Instrument Corp. · General Hospital
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Mar 1984
Decision
87d
Days
Class 2
Risk

K834436 is an FDA 510(k) clearance for the CHEMONUCLEOLYSIS NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Universal Medical Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1984 after a review of 87 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 Universal Medical Instrument Corp. devices

FDA 510(k) Submission Details - K834436

510(k) Number K834436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date March 15, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
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 465
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K834436.
THINWALL PUNCTURE NEEDLE
K841704 · Meadox Surgimed, Inc. · Jun 1984
HYPODERMIC NEEDLES & STYLETS
K840033 · Microvasive · Apr 1984
OHIO HEAT REFLECTING PATCH
K840967 · Ohio Medical Products · Mar 1984
INTRADISCAL THERAPY TRAY
K834553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1984
INTRADISCAL THERAPY TRAY
K832858 · Ulti-Med Intl., Inc. · Sep 1983
NEONATAL LUMBAR PUNCTURE TRAY
K832556 · American Pharmaseal Div. Ahsc · Sep 1983