Cleared Traditional

K000001 - WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

K000001 is an FDA 510(k) clearance for WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHES..., 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 154-day FDA review.

K000001 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
154d
Days
Class 2
Risk

K000001 is an FDA 510(k) clearance for the WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM. 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 5, 2000 after a review of 154 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 - K000001

510(k) Number K000001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2000
Decision Date June 05, 2000
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
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 K000001.
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · Boston Scientific Scimed, Inc. · Jul 2002
VIABAHN ENDOPROSTHESIS
K013648 · W.L. Gore & Associates, Inc. · Jan 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · Boston Scientific Corp · Dec 2000
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510 · Boston Scientific Corp · Nov 1999
INTRACOIL PERIPHERAL STENT
K990221 · Intratherapeutics, Inc. · Jun 1999
WALLSTENT ENDOPROSTHESIS
K982184 · Boston Scientific Scimed, Inc. · Jul 1998