Cleared Traditional

L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (K897181) - FDA 510(k) Clearance

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

K897181 · Intl. Medical Marketing, Inc. · Gastroenterology & Urology device
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Mar 1990
Decision
89d
Days
Class 2
Risk

K897181 is an FDA 510(k) clearance for the L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Intl. Medical Marketing, Inc. (Ridge, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Intl. Medical Marketing, Inc. devices

Submission Details

510(k) Number K897181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 28, 1989
Decision Date March 27, 1990
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPD Tube, Feeding
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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.