Cleared Traditional

K843883 - STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN (FDA 510(k) Clearance)

K843883 · Applied Medical Devices, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
72d
Days
-
Risk

K843883 is an FDA 510(k) clearance for the STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN.

Submitted by Applied Medical Devices, Inc. (Centennial, US). The FDA issued a Cleared decision on December 13, 1984 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Applied Medical Devices, Inc. devices

Submission Details

510(k) Number K843883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date December 13, 1984
Days to Decision 72 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
42d faster than avg
Panel avg: 114d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -