Cleared Traditional

K833628 - LUMEN-4 URODYNAMIC CATHETER

K833628 is an FDA 510(k) clearance for LUMEN-4 URODYNAMIC CATHETER, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K833628 · Surgitek · Gastroenterology & Urology device
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Nov 1983
Decision
45d
Days
Class 2
Risk

K833628 is an FDA 510(k) clearance for the LUMEN-4 URODYNAMIC CATHETER. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Surgitek devices

FDA 510(k) Submission Details - K833628

510(k) Number K833628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date November 28, 1983
Days to Decision 45 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
86d faster than avg
Panel avg: 131d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 37
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