Cleared Traditional

K830483 - COONS SOFT STENT

K830483 is an FDA 510(k) clearance for COONS SOFT STENT, manufactured by Medi-Tech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K830483 · Medi-Tech, Inc. · Gastroenterology & Urology device
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Mar 1983
Decision
22d
Days
Class 2
Risk

K830483 is an FDA 510(k) clearance for the COONS SOFT STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Walker, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 22 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 Medi-Tech, Inc. devices

FDA 510(k) Submission Details - K830483

510(k) Number K830483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date March 09, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 364
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K830483.
USCI ENDOPROSTHESIS
K834574 · C.R. Bard, Inc. · Apr 1984
BILIARY INDWELLING STENT
K834351 · Hobbs Medical, Inc. · Mar 1984
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
K833937 · Universal Medical Instrument Corp. · Jan 1984
PIGTAIL STENTS
K821819 · American Endoscopy, Inc. · Aug 1982
PIGTAIL NASAL CATHETERS
K821817 · American Endoscopy, Inc. · Aug 1982