Cleared Traditional

K133148 - BIOMARC COAXIAL NEEDLE

K133148 is an FDA 510(k) clearance for BIOMARC COAXIAL NEEDLE, manufactured by Carbon Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FBK cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K133148 · Carbon Medical Technologies, Inc. · General & Plastic Surgery device
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May 2014
Decision
208d
Days
Class 2
Risk

K133148 is an FDA 510(k) clearance for the BIOMARC COAXIAL 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 May 13, 2014 after a review of 208 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Carbon Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K133148

510(k) Number K133148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date May 13, 2014
Days to Decision 208 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 115d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery 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 K133148.
EndoChoice Select Injection Needle
K151475 · Endochoice, Inc. · Feb 2016
iSnare system-Lariat
K152035 · United States Endoscopy Group, Inc. · Oct 2015
Injection Needle
K150434 · Micro-Tech (Nanjing) Co., Ltd. · Jun 2015
INJECTION NEEDLE
K132065 · Endochoice, Inc. · Jan 2014
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
K113634 · Cook Ireland, Ltd. · Feb 2012
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · Wilson-Cook Medical, Inc. · Jul 2011