Cleared Traditional

CORMED HUBER POINT NEEDLE (K843083) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K843083 · Cormed, Inc., Sub. C.R.Bard, Inc. · General & Plastic Surgery device
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Sep 1984
Decision
30d
Days
Class 1
Risk

K843083 is an FDA 510(k) clearance for the CORMED HUBER POINT NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Cormed, Inc., Sub. C.R.Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Cormed, Inc., Sub. C.R.Bard, Inc. devices

Submission Details

510(k) Number K843083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date September 05, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 7
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K843083.
CapnoSpot™ Pneumothorax Decompression Indicator
K223625 · Pneumeric, Inc. · Mar 2023
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · Sherwood Medical Co. · Nov 1994
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · Travenol Laboratories, S.A. · Jul 1983
STERILE, DISPOSABLE, HYPODERMIC NEEDLES
K830378 · Abco Dealers, Inc. · Mar 1983
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
K801457 · Medline Industries, Inc. · Jul 1980