Cleared Traditional

K833782 - SURGITEK ALL SILICONE INFECTION DOUBJ

K833782 is an FDA 510(k) clearance for SURGITEK ALL SILICONE INFECTION DOUBJ, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K833782 · Surgitek · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
157d
Days
Class 2
Risk

K833782 is an FDA 510(k) clearance for the SURGITEK ALL SILICONE INFECTION DOUBJ. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on April 2, 1984 after a review of 157 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 Surgitek devices

FDA 510(k) Submission Details - K833782

510(k) Number K833782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1983
Decision Date April 02, 1984
Days to Decision 157 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 131d · This submission: 157d
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 K833782.
MENTOR UNIVERSAL URETERAL STENT SET
K851870 · Mentor Corp. · Jul 1985
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S
K850175 · Mentor Corp. · Mar 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · Mentor Corp. · Feb 1985
URETERAL DOUBLE PIGTAIL STENT
K834401 · Hobbs Medical, Inc. · Mar 1984
SILITEK URINARY DIVERSION STENT
K840059 · Surgitek · Feb 1984
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · Surgitek · Oct 1983