Cleared Traditional

GASTROTOPO (K861291) - FDA 510(k) Clearance

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

K861291 · Houston Biomedical, Inc. · Gastroenterology & Urology device
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May 1987
Decision
403d
Days
Class 2
Risk

K861291 is an FDA 510(k) clearance for the GASTROTOPO. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Houston Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on May 15, 1987 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Houston Biomedical, Inc. devices

Submission Details

510(k) Number K861291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date May 15, 1987
Days to Decision 403 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
273d slower than avg
Panel avg: 130d · This submission: 403d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 181
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K861291.
BARD/ANGIOMED STENTS
K896391 · C.R. Bard, Inc. · Mar 1990
COOK-GIANTURCO BILIARY Z STENT
K882610 · Cook, Inc. · Apr 1989
MODIFIED COPE SUTURE ANCHOR
K873606 · Cook, Inc. · Jun 1988
BARD BALLOON DILATATION SYSTEM
K863437 · C.R. Bard, Inc. · Oct 1986
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · C.R. Bard, Inc. · Sep 1985