510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864040Substantially Equivalent

Bard Eska Jonas Silicone-Silver Penile Prosthesis

C.R. Bard Inc, Murray Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864040 is the FDA 510(k) clearance record for BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS, a class II device, cleared for C.R. Bard, Inc. on under FDA product code FAE (Prosthesis, Penile). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K864040.

Clearance record

Decision date
Received
(8 days to decision)
Product code
FAE Prosthesis, Penile
Regulation
21 CFR 876.3630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 111 Spring St., Murray Hill NJ
Third party review
No

Clearances, product code FAE

Trailing 12 months

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

FDA records show no clearances under product code FAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAE, 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