Cleared Special

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (K021901) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021901 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
29d
Days
Class 2
Risk

K021901 is an FDA 510(k) clearance for the WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 9, 2002 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K021901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2002
Decision Date July 09, 2002
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 44
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K021901.
Ultraflex™ Tracheobronchial Stent System
K230269 · Boston Scientific Corporation · Jul 2023
Through the Scope Tracheal Stent System
K220424 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2022
Tracheal Stent System (Y-Shaped)
K212403 · Micro-Tech (Nanjing) Co., Ltd. · Oct 2021
Tracheal Stent System
K202204 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2021
HANAROSTENT Trachea/Bronchium (CCC)
K201342 · M.I. Tech Co., Ltd. · Dec 2020
AEROmini Tracheobronchial Stent System
K181200 · Merit Medical Systems, Inc. · Sep 2018