Cleared Traditional

K925621 - IRRIGATION/ASPIRATION TUBING SET

K925621 is an FDA 510(k) clearance for IRRIGATION/ASPIRATION TUBING SET, manufactured by Kirwan Surgical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

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

FDA 510(k) Submission Details - K925621

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

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 72
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K925621.
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