Cleared Traditional

K910691 - NORTEC URETERAL STENT

K910691 is an FDA 510(k) clearance for NORTEC URETERAL STENT, manufactured by North American Sterilization & Packaging Co.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K910691 · North American Sterilization & Packaging Co. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1991
Decision
177d
Days
Class 2
Risk

K910691 is an FDA 510(k) clearance for the NORTEC URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 177 days - an extended review cycle.

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 North American Sterilization & Packaging Co. devices

FDA 510(k) Submission Details - K910691

510(k) Number K910691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1991
Decision Date August 15, 1991
Days to Decision 177 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
46d slower than avg
Panel avg: 131d · This submission: 177d
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 97
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K910691.
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BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
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SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · Medical Engineering Corp. · Mar 1991