Cleared Traditional

K781664 - SILASTIC NEPHROSTOMY SYSTEM (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K781664 · Dow Corning Corp. Healthcare Industries Materials · General & Plastic Surgery device
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Jan 1979
Decision
116d
Days
Class 1
Risk

K781664 is an FDA 510(k) clearance for the SILASTIC NEPHROSTOMY SYSTEM. Classified as Catheter, Nephrostomy, General & Plastic Surgery (product code GBO), Class I - General Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on January 22, 1979 after a review of 116 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.

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Submission Details

510(k) Number K781664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1978
Decision Date January 22, 1979
Days to Decision 116 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
2d slower than avg
Panel avg: 114d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBO Catheter, Nephrostomy, General & Plastic Surgery
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.