Cleared Special

K982184 - WALLSTENT ENDOPROSTHESIS

K982184 is the FDA 510(k) clearance for WALLSTENT ENDOPROSTHESIS by Boston Scientific Scimed, Inc.. It is a Class 2 General & Plastic Surgery device (product code JCT) cleared through the Special 510(k) pathway after a 29-day FDA review.

K982184 · Boston Scientific Scimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
29d
Days
Class 2
Risk

K982184 is an FDA 510(k) clearance for the WALLSTENT 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 21, 1998 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 K982184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date July 21, 1998
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
Combination Product No
PCCP Authorized No
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 28
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K982184.
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 TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510 · Boston Scientific Corp · Nov 1999
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
ULTRAFLEX
K963241 · Boston Scientific Corp · Nov 1996