Cleared Traditional

K925061 - HELLER TRANSILLUMINATING STYLETTE

K925061 is an FDA 510(k) clearance for HELLER TRANSILLUMINATING STYLETTE, manufactured by Device Resources. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 629-day FDA review.

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.

View all Device Resources devices

FDA 510(k) Submission Details - K925061

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.

KNT Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K925061.
BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K935045 · Biosearch Medical Products, Inc. · Aug 1994
LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
K920579 · Wilson-Cook Medical, Inc. · Jul 1994
ENTEROCLYSIS TUBE
K923002 · Biosearch Medical Products, Inc. · Jun 1994
DUAL PORT ENTERAL Y-ADAPTOR
K923168 · Orion Life Systems, Inc. · Jun 1994
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · Abbott Laboratories · Jun 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994