Cleared Traditional

K771574 - LEE ASPIRATION NEEDLE

K771574 is an FDA 510(k) clearance for LEE ASPIRATION NEEDLE, manufactured by Radiation Development Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K771574 · Radiation Development Co., Inc. · General & Plastic Surgery device
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Dec 1977
Decision
113d
Days
Class 1
Risk

K771574 is an FDA 510(k) clearance for the LEE ASPIRATION NEEDLE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Radiation Development Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1977 after a review of 113 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 Radiation Development Co., Inc. devices

FDA 510(k) Submission Details - K771574

510(k) Number K771574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1977
Decision Date December 06, 1977
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

Product Code GDM Needle, Aspiration And Injection, Reusable
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.