Cleared Traditional

CUATICO MYELOGRAPHY NEEDLES (K813367) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K813367 · Dlp, Inc. · General & Plastic Surgery device
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Jan 1982
Decision
36d
Days
Class 1
Risk

K813367 is an FDA 510(k) clearance for the CUATICO MYELOGRAPHY NEEDLES. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Dlp, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1982 after a review of 36 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 Dlp, Inc. devices

Submission Details

510(k) Number K813367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1981
Decision Date January 05, 1982
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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

Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K813367.
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
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
K801457 · Medline Industries, Inc. · Jul 1980
IOPSY TRAY FOR SOFT TISSUE BIOPSY
K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1977