510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050232Substantially Equivalent

Rigiflex Single-Use Achalasia Balloon Dilator

Boston Scientific Corporation, Natick, MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050232 is the FDA 510(k) clearance record for RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR, a class II device, cleared for Boston Scientific Corp on under FDA product code PID (Esophageal Dilator Balloon With Or Without Electrode Sensors). FDA's definition for product code PID reads: "To dilate the lower esophageal sphincter of patients with Achalasia". FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show one recall naming K050232.

Clearance record

Decision date
Received
(38 days to decision)
Product code
PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PID

Trailing 12 months

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

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