Cleared Traditional

IRRIGATION/ASPIRATION TUBING SET (K925621) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K925621 · Kirwan Surgical Products, Inc. · General & Plastic Surgery device
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May 1993
Decision
182d
Days
Class 1
Risk

K925621 is an FDA 510(k) clearance for the IRRIGATION/ASPIRATION TUBING SET. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Kirwan Surgical Products, Inc. (Rockland, US). The FDA issued a Cleared decision on May 7, 1993 after a review of 182 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 Kirwan Surgical Products, Inc. devices

Submission Details

510(k) Number K925621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date May 07, 1993
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
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.