Cleared Traditional

K926496 - SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN

K926496 is an FDA 510(k) clearance for SIL-SLIP (COATED/REGULAR(NON-COATED)THO..., manufactured by Sil-Med Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 876-day FDA review.

K926496 · Sil-Med Corp. · General & Plastic Surgery device
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May 1995
Decision
876d
Days
Class 1
Risk

K926496 is an FDA 510(k) clearance for the SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 876 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

FDA 510(k) Submission Details - K926496

510(k) Number K926496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1992
Decision Date May 24, 1995
Days to Decision 876 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
761d slower than avg
Panel avg: 115d · This submission: 876d
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 K926496.
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