510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021856Substantially Equivalent

Porges Ureteral Catheters, Models Acn6xx, Acn5xx, Ac5b, Ac5c07, Acp5xx, Acp2xx, Acp3xx, Acp4xx, Acp6xx

Porges Corp., Le Plessis Robinson Cedex, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021856 is the FDA 510(k) clearance record for PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX, a class II device, cleared for Porges S.A. on under FDA product code EYB (Catheter, Ureteral, Gastro-Urology). FDA records list 22 510(k) clearances for Porges S.A., from to . As of , FDA records show no recalls naming K021856.

Clearance record

Decision date
Received
(133 days to decision)
Product code
EYB Catheter, Ureteral, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Porges S.A. Centre D'Affaires, Le Plessis Robinson Cedex, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EYB

Trailing 12 months

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

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