Cleared Traditional

K933815 - BARD ENDOSCOPIC INJECTION SYSTEM

K933815 is the FDA 510(k) clearance for BARD ENDOSCOPIC INJECTION SYSTEM by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K933815 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Dec 1993
Decision
119d
Days
Class 2
Risk

K933815 is an FDA 510(k) clearance for the BARD ENDOSCOPIC INJECTION SYSTEM. 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 December 1, 1993 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K933815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date December 01, 1993
Days to Decision 119 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K933815.
INJECTION NEEDLE
K953338 · Boston Scientific Corp · Aug 1995
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
K941305 · Wilson-Cook Medical, Inc. · Jun 1994
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
K921800 · Mill-Rose Laboratory · Feb 1993
NEEDLE
K924102 · United States Endoscopy Group, Inc. · Nov 1992
WILSON-COOK ASPIRATION HANDLE
K903668 · Wilson-Cook Medical, Inc. · Oct 1990