Cleared Traditional

K915841 - BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC

K915841 is an FDA 510(k) clearance for BARD GAUDERER UNIVERSAL PERCUTANEOUS EN..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 549-day FDA review.

K915841 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
549d
Days
Class 2
Risk

K915841 is an FDA 510(k) clearance for the BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 549 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K915841

510(k) Number K915841 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 24, 1991
Decision Date June 25, 1993
Days to Decision 549 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
418d slower than avg
Panel avg: 131d · This submission: 549d
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 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K915841.
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · Abbott Laboratories · Oct 1993
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · Abbott Laboratories · Aug 1993
GASTROPORT II
K924308 · Sandoz Nutrition · Jul 1993
STOMA MEASURING DEVICE
K923692 · Applied Medical Technologies · May 1993
PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT
K923983 · Sandoz Nutrition · Apr 1993
NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM
K915837 · C.R. Bard, Inc. · Mar 1993