Cleared Special

Endoscopic Injection Needle

K172227 · Carbon Medical Technologies, Inc. · Gastroenterology & Urology

Aug 2017

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K172227 is an FDA 510(k) clearance for the Endoscopic Injection Needle, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Carbon Medical Technologies, Inc. (Saint Paul, US). The FDA issued a Cleared decision on August 23, 2017, 29 days after receiving the submission on July 25, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K172227 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	FBK — Endoscopic Injection Needle, Gastroenterology-urology
Device Class	Class II — 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.