Cleared Traditional

K904231 - MODEL OSP

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

K904231 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
3d faster than avg
Panel avg: 130d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 69
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K904231.
ECHOSIGHT STENT SET
K914280 · Cook Urological, Inc. · Jan 1992
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · Mentor Corp. · Sep 1991
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · Mentor Corp. · Mar 1988
MENTOR BLACK LIGHT URETERAL STENT SET
K873557 · Mentor Corp. · Feb 1988