510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831788Substantially Equivalent

Urodynamic Analyzer

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

K831788 is the FDA 510(k) clearance record for URODYNAMIC ANALYZER, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FAN (Sigmoidoscope, Rigid, Electrical). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K831788.

Clearance record

Decision date
Received
(101 days to decision)
Product code
FAN Sigmoidoscope, Rigid, Electrical
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FAN

Trailing 12 months

FDA records hold no clearances under product code FAN in the trailing twelve months.

FDA records show no clearances under product code FAN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260