510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172128Substantially Equivalent

EsoFLIP® ES-310 Balloon Catheter

Crospon, Ltd., Galway, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172128 is the FDA 510(k) clearance record for EsoFLIP® ES-310 Balloon Catheter, a class II device, cleared for Crospon, Ltd. on under FDA product code PIE (Esophageal Dilator With Balloon And Electrode Sensors). FDA's definition for product code PIE reads: "To dilate esophageal strictures with a dilating balloon and electrode sensors". FDA records list 12 510(k) clearances for Crospon, Ltd., from to . As of , FDA records show no recalls naming K172128.

Clearance record

Decision date
Received
(131 days to decision)
Product code
PIE Esophageal Dilator With Balloon And Electrode Sensors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Crospon, Ltd. Galway Business Park, Galway, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIE

Trailing 12 months

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

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