Cleared Traditional

K840529 - STEIGER TUNNELING INSTRUMENT 285

K840529 is the FDA 510(k) clearance for STEIGER TUNNELING INSTRUMENT 285 by Evermed, Inc.. It is a Class 2 Cardiovascular device (product code DRC) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K840529 · Evermed, Inc. · Cardiovascular device
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Mar 1984
Decision
33d
Days
Class 2
Risk

K840529 is an FDA 510(k) clearance for the STEIGER TUNNELING INSTRUMENT 285. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Evermed, Inc. (Walker, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight 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 Evermed, Inc. devices

Submission Details

510(k) Number K840529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date March 12, 1984
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRC Trocar

All 27
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K840529.
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