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 the FDA 510(k) clearance for ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (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)
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.

View all Boston Scientific Corp devices

Submission Details

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
60d slower than avg
Panel avg: 130d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K014297.
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
K030855 · Boston Scientific Corp · Apr 2003
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · Boston Scientific Corp · Sep 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp · Aug 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · Rusch Intl. · Feb 2002
RUSCH CANTOR TUBE
K010798 · Rusch Intl. · Feb 2002
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001