Cleared Special

K050688 - TEGRESS IMPLANT NEEDLE

K050688 is an FDA 510(k) clearance for TEGRESS IMPLANT NEEDLE, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Special 510(k) pathway after a 20-day FDA review.

K050688 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
20d
Days
Class 2
Risk

K050688 is an FDA 510(k) clearance for the TEGRESS IMPLANT NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 6, 2005 after a review of 20 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 - K050688

510(k) Number K050688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2005
Decision Date April 06, 2005
Days to Decision 20 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
111d faster than avg
Panel avg: 131d · This submission: 20d
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 K050688.
INJECTRA INJECTION NEEDLE
K061222 · Medi-Globe Corp. · Jul 2006
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
K043383 · Physion, Inc. · Oct 2005
UROPLASTY RIGID ENDOSCOPIC NEEDLE
K051905 · Uroplasty, Inc. · Aug 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
K042615 · Carbon Medical Technologies, Inc. · Nov 2004
VARICES NEEDLE
K031238 · Scandimed. A.S. · Oct 2004
K050688 · TEGRESS IMPLANT NEEDLE
Download PDF FDA Summary C.R. Bard, Inc.