Cleared Traditional

K953593 - RUSCH TRACHEAL BRONCHIAL Y STENT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953593 · Rusch, Inc. · General & Plastic Surgery device
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Oct 1995
Decision
74d
Days
Class 2
Risk

K953593 is an FDA 510(k) clearance for the RUSCH TRACHEAL BRONCHIAL Y STENT. Classified as Prosthesis, Tracheal, Expandable, Polymeric (product code NYT), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 74 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 Rusch, Inc. devices

Submission Details

510(k) Number K953593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 31, 1995
Decision Date October 13, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 114d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NYT Prosthesis, Tracheal, Expandable, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
Definition The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls And Indicated For The Treatment Of Tracheobronchial Strictures Produced By Malignant Neoplasms Or In Benign Strictures, After All Alternative Therapies Have Been Exhausted.
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.