Cleared Traditional

K813367 - CUATICO MYELOGRAPHY NEEDLES

K813367 is an FDA 510(k) clearance for CUATICO MYELOGRAPHY NEEDLES, manufactured by Dlp, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

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.

FDA 510(k) Submission Details - K813367

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

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 106
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K813367.
MSI STERNUM ASPIRATION NEEDLE
K820070 · Creative Research and Mfg., Inc. · Feb 1982
POTTS-COURNAND STYLE NEEDLE
K813448 · Ocean Medical Products, Ltd. · Jan 1982
CHIBA SKINNY NEEDLE
K813460 · Ocean Medical Products, Ltd. · Jan 1982
DISPOSABLE CHIBA-TYPE NEEDLE
K813368 · Dlp, Inc. · Jan 1982
A.D.T. REUSABLE BONE MARROW NEEDLE
K811771 · Lab Industries, Inc. · Jul 1981
MSI BONE MARROW BIOPSY NEEDLE W/J TIP
K810248 · Creative Research and Mfg., Inc. · Mar 1981
K813367 · CUATICO MYELOGRAPHY NEEDLES
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