Cleared Special

K022648 - ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

K022648 is an FDA 510(k) clearance for ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 27-day FDA review.

K022648 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
27d
Days
Class 2
Risk

K022648 is an FDA 510(k) clearance for the ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521. 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 September 5, 2002 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022648

510(k) Number K022648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date September 05, 2002
Days to Decision 27 days
Submission Type Special
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
104d faster than avg
Panel avg: 131d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K022648.
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
K030855 · Boston Scientific Corp · Apr 2003
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
K022112 · Fortune Medical Instrument Corp. · Apr 2003
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
K023344 · Bowel Management Systems, LLC · Nov 2002
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
K021493 · Andersen Products, Inc. · Aug 2002
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
K022648 · ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
Download PDF FDA Summary Boston Scientific Corp