Cleared Traditional

SLIT CATHETER SYSTEM (K803093) - FDA 510(k) Clearance

K803093 · Howmedica Corp. · Orthopedic device
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Jan 1981
Decision
31d
Days
-
Risk

K803093 is an FDA 510(k) clearance for the SLIT CATHETER SYSTEM.

Submitted by Howmedica Corp. (Walker, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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 Howmedica Corp. devices

Submission Details

510(k) Number K803093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date January 08, 1981
Days to Decision 31 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -