Cleared Traditional

K833719 - PREPACELL THIN NEEDLE ASPIRATION TRAY

K833719 is an FDA 510(k) clearance for PREPACELL THIN NEEDLE ASPIRATION TRAY, manufactured by Applied Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K833719 · Applied Medical Devices, Inc. · Gastroenterology & Urology device
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Jan 1984
Decision
93d
Days
Class 2
Risk

K833719 is an FDA 510(k) clearance for the PREPACELL THIN NEEDLE ASPIRATION TRAY. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Applied Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Medical Devices, Inc. devices

FDA 510(k) Submission Details - K833719

510(k) Number K833719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1983
Decision Date January 25, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 130d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K833719.
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984
FOLEY CATHETERIZATION TRAY-VARIOUS
K832363 · Inmed Corp. · Mar 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · C.R. Bard, Inc. · Feb 1984
CURITY 100% SILICONE COUDE' CATHETER
K833790 · The Kendal Co. · Dec 1983
CATHETER CARE TRAY
K832389 · Inmed Corp. · Sep 1983
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · Electromedics, Inc. · Sep 1983