Cleared Traditional

VISI-FLOW IRRIGATOR (K832299) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832299 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Aug 1983
Decision
44d
Days
Class 2
Risk

K832299 is an FDA 510(k) clearance for the VISI-FLOW IRRIGATOR. Classified as Irrigator, Ostomy (product code EXD), Class II - Special Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Walker, US). The FDA issued a Cleared decision on August 26, 1983 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5895 - 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K832299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1983
Decision Date August 26, 1983
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EXD Irrigator, Ostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5895
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.