Cleared Traditional

MEDIASTINAL SILICONE DRAINS (K942709) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K942709 · Sil-Med Corp. · General & Plastic Surgery device
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Jan 1996
Decision
575d
Days
Class 1
Risk

K942709 is an FDA 510(k) clearance for the MEDIASTINAL SILICONE DRAINS. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 575 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Sil-Med Corp. devices

Submission Details

510(k) Number K942709 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 08, 1994
Decision Date January 04, 1996
Days to Decision 575 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
460d slower than avg
Panel avg: 115d · This submission: 575d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBW Catheter, Peritoneal
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.