Cleared Traditional

ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (K961194) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K961194 · Sil-Med Corp. · General & Plastic Surgery device
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Aug 1996
Decision
134d
Days
Class 1
Risk

K961194 is an FDA 510(k) clearance for the ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN. 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 August 8, 1996 after a review of 134 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 Sil-Med Corp. devices

Submission Details

510(k) Number K961194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1996
Decision Date August 08, 1996
Days to Decision 134 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
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.