Cleared Traditional

K780473 - ILEX STOMA SEAL AND PROTECTIVE CREAM

K780473 is the FDA 510(k) clearance for ILEX STOMA SEAL AND PROTECTIVE CREAM by Virgil Pichierri. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K780473 · Virgil Pichierri · Gastroenterology & Urology device
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May 1978
Decision
53d
Days
Class 1
Risk

K780473 is an FDA 510(k) clearance for the ILEX STOMA SEAL AND PROTECTIVE CREAM. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Virgil Pichierri (Mchenry, US). The FDA issued a Cleared decision on May 16, 1978 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 Virgil Pichierri devices

Submission Details

510(k) Number K780473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1978
Decision Date May 16, 1978
Days to Decision 53 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
77d faster than avg
Panel avg: 130d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K780473.
COLOPLAST CARBON GAS FILTER
K791581 · C.R. Bard, Inc. · Oct 1979
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · Hollister, Inc. · Sep 1978
OSTOMY APPLIANCE BELT
K781088 · E. R. Squibb & Sons, Inc. · Aug 1978
ACTIVE-LIFE
K780454 · E. R. Squibb & Sons, Inc. · Apr 1978
SNAP-FIT
K780511 · E. R. Squibb & Sons, Inc. · Apr 1978
COLORPLAST TRANSVERSE SYSTEM
K771775 · C.R. Bard, Inc. · Sep 1977