Cleared Traditional

K844458 - ND:YAG LASER PULMONARY OBSTRUCTION (FDA 510(k) Clearance)

K844458 · Endo Lase, Inc. · Cardiovascular device
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Jan 1985
Decision
49d
Days
-
Risk

K844458 is an FDA 510(k) clearance for the ND:YAG LASER PULMONARY OBSTRUCTION.

Submitted by Endo Lase, Inc. (Washington, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Endo Lase, Inc. devices

Submission Details

510(k) Number K844458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1984
Decision Date January 03, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -