Cleared Traditional

K904231 - MODEL OSP, SANDHILL AMS

K904231 is an FDA 510(k) clearance for MODEL OSP, manufactured by Sandhill Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K904231 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
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Jan 1991
Decision
127d
Days
Class 2
Risk

K904231 is an FDA 510(k) clearance for the MODEL OSP, SANDHILL AMS. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on January 2, 1991 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 Sandhill Scientific, Inc. devices

FDA 510(k) Submission Details - K904231

510(k) Number K904231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date January 02, 1991
Days to Decision 127 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
4d faster than avg
Panel avg: 131d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 103
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K904231.
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · Vas-Cath, Inc. · Apr 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · Medical Engineering Corp. · Mar 1991
VAS-CATH URETERAL STENT CATHETER
K894357 · Vas-Cath, Inc. · Oct 1989
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
PORGES URETERAL STENT
K881744 · Bivona Medical Technologies · May 1988