Cleared Traditional

K014297 - ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT

Also marketed or referenced as:
ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE SECURI-T INITIAL P

K014297 is an FDA 510(k) clearance for ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K014297 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
190d
Days
Class 2
Risk

K014297 is an FDA 510(k) clearance for the ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 9, 2002 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 - K014297

510(k) Number K014297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2001
Decision Date July 09, 2002
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.

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 K014297.
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp · Aug 2002
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
K021991 · Syncro Medical Innovations, Inc. · Jul 2002
INFANT FEEDING TUBES
K020005 · Promedic, Inc. · Jul 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K021034 · Tfx Medical, Inc. · Jun 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K020985 · Tfx Medical, Inc. · Jun 2002
PPD BALLOON DILATATION CATHETER
K020379 · Telemed Systems, Inc. · May 2002
K014297 · ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
Download PDF FDA Summary Boston Scientific Corp