Cleared Traditional

K934116 - WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION

K934116 is an FDA 510(k) clearance for WALLSTENT TRACHEOBRONCHIAL PROSTHESIS M..., manufactured by Boston Scientific Scimed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCT cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K934116 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
281d
Days
Class 2
Risk

K934116 is an FDA 510(k) clearance for the WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION. 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 June 2, 1994 after a review of 281 days - an extended review cycle.

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

FDA 510(k) Submission Details - K934116

510(k) Number K934116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 25, 1993
Decision Date June 02, 1994
Days to Decision 281 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 115d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCT Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K934116.
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · Boston Scientific Scimed, Inc. · Jul 1996
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961507 · Boston Scientific Scimed, Inc. · Jul 1996
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
K945494 · Boston Scientific Scimed, Inc. · Mar 1995
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
K891411 · Cook, Inc. · Dec 1991