Cleared Traditional

KLEIN NEEDLE (K881784) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K881784 · E.L. Medico Intl., Inc. · General & Plastic Surgery device
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Dec 1988
Decision
219d
Days
Class 1
Risk

K881784 is an FDA 510(k) clearance for the KLEIN NEEDLE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by E.L. Medico Intl., Inc. (San Clemente, US). The FDA issued a Cleared decision on December 2, 1988 after a review of 219 days - an extended review 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: 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 E.L. Medico Intl., Inc. devices

Submission Details

510(k) Number K881784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1988
Decision Date December 02, 1988
Days to Decision 219 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
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.