Cleared Special

K042882 - ENTERYX INJECTION CATHETER

K042882 is an FDA 510(k) clearance for ENTERYX INJECTION CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Special 510(k) pathway after a 21-day FDA review.

K042882 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
21d
Days
Class 2
Risk

K042882 is an FDA 510(k) clearance for the ENTERYX INJECTION CATHETER. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 9, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 - K042882

510(k) Number K042882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date November 09, 2004
Days to Decision 21 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
110d faster than avg
Panel avg: 131d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 87
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K042882.
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
K043383 · Physion, Inc. · Oct 2005
UROPLASTY RIGID ENDOSCOPIC NEEDLE
K051905 · Uroplasty, Inc. · Aug 2005
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
K042615 · Carbon Medical Technologies, Inc. · Nov 2004
VARICES NEEDLE
K031238 · Scandimed. A.S. · Oct 2004
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
K030451 · Carbon Medical Technologies, Inc. · Apr 2003
K042882 · ENTERYX INJECTION CATHETER
Download PDF FDA Summary Boston Scientific Corp