Cleared Traditional

K897050 - WILSON-COOK LUNG BIOPSY NEEDLE

K897050 is the FDA 510(k) clearance for WILSON-COOK LUNG BIOPSY NEEDLE by Wilson-Cook Medical, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K897050 · Wilson-Cook Medical, Inc. · General & Plastic Surgery device
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Apr 1990
Decision
119d
Days
Class 1
Risk

K897050 is an FDA 510(k) clearance for the WILSON-COOK LUNG BIOPSY NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K897050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date April 16, 1990
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 37
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K897050.
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
K914608 · Dlp, Inc. · Jan 1992
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991
BONE MARROW BIOPSY TRAY
K912074 · Manan Medical Products, Inc. · Aug 1991
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · Dlp, Inc. · Jan 1990
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · E-Z-Em, Inc. · Dec 1989
THORACENTISIS KIT
K894326 · Mill-Rose Laboratory · Jul 1989