Cleared Traditional

K896019 - MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGN...

K896019 is the FDA 510(k) clearance for MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGN... by Dlp, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K896019 · Dlp, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
79d
Days
Class 1
Risk

K896019 is an FDA 510(k) clearance for the MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 79 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 K896019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date January 03, 1990
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 38
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K896019.
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991
BONE MARROW BIOPSY TRAY
K912074 · Manan Medical Products, Inc. · Aug 1991
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · E-Z-Em, Inc. · Dec 1989
THORACENTISIS KIT
K894326 · Mill-Rose Laboratory · Jul 1989
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988