510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930827Substantially Equivalent

Bard Stabilizing Cannula

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

K930827 is the FDA 510(k) clearance record for BARD STABILIZING CANNULA, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAJ reads: "To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K930827.

Clearance record

Decision date
Received
(86 days to decision)
Product code
FAJ Cystoscope And Accessories, Flexible/Rigid
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 FAJ

Trailing 12 months
5 clearances under product code FAJ in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FAJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20262
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260