Cleared Traditional

K010797 - RUSCH MILLER-ABBOTT TUBE

K010797 is an FDA 510(k) clearance for RUSCH MILLER-ABBOTT TUBE, manufactured by Rusch Intl.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K010797 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
347d
Days
Class 2
Risk

K010797 is an FDA 510(k) clearance for the RUSCH MILLER-ABBOTT TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on February 26, 2002 after a review of 347 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K010797

510(k) Number K010797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date February 26, 2002
Days to Decision 347 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
216d slower than avg
Panel avg: 131d · This submission: 347d
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 644
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K010797.
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K020985 · Tfx Medical, Inc. · Jun 2002
PPD BALLOON DILATATION CATHETER
K020379 · Telemed Systems, Inc. · May 2002
INDWELLING FECAL MANAGEMENT SYSTEM
K012113 · Bowel Management Systems, LLC · May 2002
RUSCH CANTOR TUBE
K010798 · Rusch Intl. · Feb 2002
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · Zevex, Inc. · Nov 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001
K010797 · RUSCH MILLER-ABBOTT TUBE
Download PDF FDA Summary Rusch Intl.