Cleared Traditional

ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR (K980917) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980917 · Fortune Medical Instrument Corp. · Gastroenterology & Urology device
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May 1998
Decision
77d
Days
Class 2
Risk

K980917 is an FDA 510(k) clearance for the ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV .... Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Fortune Medical Instrument Corp. (Irvine, US). The FDA issued a Cleared decision on May 27, 1998 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology 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 Fortune Medical Instrument Corp. devices

Submission Details

510(k) Number K980917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1998
Decision Date May 27, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 25
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K980917.
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