Cleared Traditional

K992510 - WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHES...

K992510 is the FDA 510(k) clearance for WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHES... by Boston Scientific Corp. It is a Class 2 General & Plastic Surgery device (product code JCT) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K992510 · Boston Scientific Corp · General & Plastic Surgery device
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Nov 1999
Decision
114d
Days
Class 2
Risk

K992510 is an FDA 510(k) clearance for the WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Plymouth, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 114 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 Corp devices

Submission Details

510(k) Number K992510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1999
Decision Date November 18, 1999
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
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 27
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K992510.
VIABAHN ENDOPROSTHESIS
K013648 · W.L. Gore & Associates, Inc. · Jan 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · Boston Scientific Corp · Dec 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K000001 · Boston Scientific Scimed, Inc. · Jun 2000
WALLSTENT ENDOPROSTHESIS
K982184 · Boston Scientific Scimed, Inc. · Jul 1998
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
K980163 · Boston Scientific Scimed, Inc. · Mar 1998
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K964121 · Boston Scientific Scimed, Inc. · Dec 1996