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FDA 510(k)

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

K-Number: K050232 · 2005-03-11

ApplicantBoston Scientific Corp
Decision Date2005-03-11
Product CodePID
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2005-03-11 under 510(k) number K050232. The device is classified under product code PID. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR?

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR is a medical device that received FDA 510(k) clearance on 2005-03-11. The listed applicant is Boston Scientific Corp. The 510(k) number is K050232.

When did RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR receive FDA 510(k) clearance?

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR received FDA 510(k) clearance on 2005-03-11, under 510(k) number K050232.

Who is the listed applicant for RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR?

The FDA product code for RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR is PID.

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Related Devices (Code: PID)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182895Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc.K132337ESOFLIP BALLOON DILATION CATHETERCrospon, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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