Cleared Special

K172227 - Endoscopic Injection Needle

K172227 is an FDA 510(k) clearance for Endoscopic Injection Needle, manufactured by Carbon Medical Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Special 510(k) pathway after a 29-day FDA review.

K172227 · Carbon Medical Technologies, Inc. · Gastroenterology & Urology device
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Aug 2017
Decision
29d
Days
Class 2
Risk

K172227 is an FDA 510(k) clearance for the Endoscopic Injection Needle. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Carbon Medical Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 23, 2017 after a review of 29 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.

View all Carbon Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K172227

510(k) Number K172227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date August 23, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
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 52
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K172227.
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
K190829 · Wilson-Cook Medical Inc./Cook Endoscopy · Dec 2019
Clear-Jet Injection Catheter
K181690 · Finemedix Co., Ltd. · Dec 2018
Repris Bladder Injection System
K180214 · Uro-1, Inc. · May 2018
Williams Cystoscopic Injection Needle
K171602 · Cook Incorporated · Jul 2017
Interject Injection Therapy Needle Catheter
K171454 · Boston Scientific Corporation · Jul 2017
Single Use Injector NM600/610
K153625 · Olympus Medical Systems Corp. · Feb 2016