Cleared Traditional

K963241 - ULTRAFLEX

K963241 is the FDA 510(k) clearance for ULTRAFLEX by Boston Scientific Corp. It is a Class 2 General & Plastic Surgery device (product code JCT) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K963241 · Boston Scientific Corp · General & Plastic Surgery device
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Nov 1996
Decision
87d
Days
Class 2
Risk

K963241 is an FDA 510(k) clearance for the ULTRAFLEX. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 87 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 Corp devices

Submission Details

510(k) Number K963241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 19, 1996
Decision Date November 14, 1996
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 27
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K963241.
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
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K964121 · Boston Scientific Scimed, Inc. · Dec 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · Boston Scientific Scimed, Inc. · Jul 1996
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961507 · Boston Scientific Scimed, Inc. · Jul 1996
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
K945494 · Boston Scientific Scimed, Inc. · Mar 1995