Cleared Traditional

K991219 - C-FLEX URETERAL STENTS

K991219 is an FDA 510(k) clearance for C-FLEX URETERAL STENTS, manufactured by Applied Medical Resources. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K991219 · Applied Medical Resources · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
70d
Days
Class 2
Risk

K991219 is an FDA 510(k) clearance for the C-FLEX URETERAL STENTS. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 70 days - a notably fast clearance 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: 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K991219

510(k) Number K991219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date June 21, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 130d · This submission: 70d
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 95
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K991219.
MESH URETERAL STENT
K011264 · Applied Medical Resources Corp. · Jul 2001
CONTOUR POLARIS URETERAL STENT
K010002 · Boston Scientific Corp · Jan 2001
DD URETERAL STENT, INTEGRAL STENT
K982974 · Rusch Intl. · Jul 1999
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
K983498 · C.R. Bard, Inc. · Dec 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · Boston Scientific Corp · Feb 1998
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc. · Jul 1996