Cleared Traditional

E-Z LOOP (K870577) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K870577 · John F. Greer Co., Inc. · Gastroenterology & Urology device
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Apr 1987
Decision
66d
Days
Class 1
Risk

K870577 is an FDA 510(k) clearance for the E-Z LOOP. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by John F. Greer Co., Inc. (Oakland, US). The FDA issued a Cleared decision on April 17, 1987 after a review of 66 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 John F. Greer Co., Inc. devices

Submission Details

510(k) Number K870577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date April 17, 1987
Days to Decision 66 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
64d faster than avg
Panel avg: 130d · This submission: 66d
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 22
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K870577.
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