510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K933815Substantially Equivalent

Bard Endoscopic Injection System

C.R. Bard Inc, Covington GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933815 is the FDA 510(k) clearance record for BARD ENDOSCOPIC INJECTION SYSTEM, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology). FDA's definition for product code FBK reads: "inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K933815.

Clearance record

Decision date
Received
(119 days to decision)
Product code
FBK Endoscopic Injection Needle, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 8195 Industrial Blvd., Covington GA
510(k) summary
Summary
Third party review
No

Clearances, product code FBK

Trailing 12 months
3 clearances under product code FBK in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FBK, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260