Cleared Traditional

HELLER TRANSILLUMINATING STYLETTE (K925061) - FDA 510(k) Clearance

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

K925061 · Device Resources · Gastroenterology & Urology device
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Jun 1994
Decision
629d
Days
Class 2
Risk

K925061 is an FDA 510(k) clearance for the HELLER TRANSILLUMINATING STYLETTE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Device Resources (Lake Bluff, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 629 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: 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.

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Submission Details

510(k) Number K925061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date June 27, 1994
Days to Decision 629 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
499d slower than avg
Panel avg: 130d · This submission: 629d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 124
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K925061.
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · Abbott Laboratories · Jan 1995
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · Boston Scientific Corp · Dec 1994
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · Abbott Laboratories · Jun 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · Abbott Laboratories · Oct 1993