Cleared Traditional

K955339 - HYDROLOGY 5000

K955339 is an FDA 510(k) clearance for HYDROLOGY 5000, manufactured by Northgate Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K955339 · Northgate Technologies, Inc. · General & Plastic Surgery device
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Mar 1996
Decision
114d
Days
Class 1
Risk

K955339 is an FDA 510(k) clearance for the HYDROLOGY 5000. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 114 days - within the typical 510(k) review window.

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: 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 Northgate Technologies, Inc. devices

FDA 510(k) Submission Details - K955339

510(k) Number K955339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date March 13, 1996
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, 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 - GBX Catheter, Irrigation

All 47
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K955339.
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K955505 · Navarre Biomedical , Ltd. · Feb 1996
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K926496 · Sil-Med Corp. · May 1995