Cleared Traditional

K961507 - WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

K961507 is the FDA 510(k) clearance for WALSTENT 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 82-day FDA review.

K961507 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
82d
Days
Class 2
Risk

K961507 is an FDA 510(k) clearance for the WALSTENT 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 July 10, 1996 after a review of 82 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 K961507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received April 19, 1996
Decision Date July 10, 1996
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 K961507.
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K964121 · Boston Scientific Scimed, Inc. · Dec 1996
ULTRAFLEX
K963241 · Boston Scientific Corp · Nov 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · Boston Scientific Scimed, Inc. · Jul 1996
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
K945494 · Boston Scientific Scimed, Inc. · Mar 1995
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
K934116 · Boston Scientific Scimed, Inc. · Jun 1994
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
K891411 · Cook, Inc. · Dec 1991