Cleared Traditional

K964121 - WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

K964121 is the FDA 510(k) clearance for WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS by Boston Scientific Scimed, Inc.. It is a Class 2 General & Plastic Surgery device (product code JCT) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K964121 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
50d
Days
Class 2
Risk

K964121 is an FDA 510(k) clearance for the WALLSTENT 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 December 4, 1996 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K964121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 15, 1996
Decision Date December 04, 1996
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 28
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K964121.
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510 · Boston Scientific Corp · Nov 1999
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
ULTRAFLEX
K963241 · Boston Scientific Corp · Nov 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · Boston Scientific Scimed, Inc. · Jul 1996
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961507 · Boston Scientific Scimed, Inc. · Jul 1996