Cleared Traditional

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS (K945494) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945494 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
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Mar 1995
Decision
115d
Days
Class 2
Risk

K945494 is an FDA 510(k) clearance for the WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 3, 1995 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3720 - 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 Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K945494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received November 08, 1994
Decision Date March 03, 1995
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCT Prosthesis, Tracheal, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCT Prosthesis, Tracheal, Expandable

All 44
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