Cleared Traditional

K960176 - DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER

K960176 is an FDA 510(k) clearance for DAVOL NASOGASTRIC SUMP TUBE W/PREVENT F..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEG cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K960176 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
190d
Days
Class 2
Risk

K960176 is an FDA 510(k) clearance for the DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER. Classified as Tube, Double Lumen For Intestinal Decompression And/or Intubation (product code FEG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on July 24, 1996 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K960176

510(k) Number K960176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date July 24, 1996
Days to Decision 190 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
59d slower than avg
Panel avg: 131d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEG Device Classification - Class 2, Special Controls

Product Code FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation
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 - FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation

All 12
Devices cleared under the same product code (FEG) and FDA review panel - the closest regulatory comparables to K960176.
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
K053410 · Kendall · Jan 2006
NEXT GENERATION SALEM SUMP
K040388 · Kendall · May 2004
KNOTT NG TUBE
K971354 · Michael M. Knott, M.D. · Nov 1997
ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE
K926073 · Surgimark, Inc. · May 1995
ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY
K935781 · Sherwood Medical Co. · Jan 1995
LOPEZ VALVE WITH NG SUMP TUBE
K921104 · Icu Medical, Inc. · Oct 1992
K960176 · DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
Download PDF FDA Summary C.R. Bard, Inc.