Cleared Traditional

K873097 - PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR ...

K873097 is an FDA 510(k) clearance for PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR ..., manufactured by Ipax, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBQ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K873097 · Ipax, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
39d
Days
Class 1
Risk

K873097 is an FDA 510(k) clearance for the PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS. Classified as Catheter, Continuous Irrigation (product code GBQ), Class I - General Controls.

Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ipax, Inc. devices

FDA 510(k) Submission Details - K873097

510(k) Number K873097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date September 04, 1987
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

GBQ Device Classification - Class 1, General Controls

Product Code GBQ Catheter, Continuous Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBQ Catheter, Continuous Irrigation

Devices cleared under the same product code (GBQ) and FDA review panel - the closest regulatory comparables to K873097.
MICROFLOW IRRIGATION SYSTEM
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K882647 · Gesco Intl., Inc. · Sep 1988
MODIFIED CURLCATH
K872787 · Quinton, Inc. · Aug 1987
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K771732 · Concept, Inc. · Sep 1977