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FDA 510(k)

Balloon BS-3

K-Number: K213195 · 2021-10-29

ApplicantFujifilm Corporation
Decision Date2021-10-29
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Balloon BS-3 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K213195. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Balloon BS-3?

Balloon BS-3 is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Fujifilm Corporation. The 510(k) number is K213195.

When did Balloon BS-3 receive FDA 510(k) clearance?

Balloon BS-3 received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213195.

Who is the listed applicant for Balloon BS-3?

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

What is the FDA product code for Balloon BS-3?

The FDA product code for Balloon BS-3 is FDA.

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Related Devices (Code: FDA)

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.

K260314Ancora-SBAspero Medical, Inc.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas CorporationK233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm CorporatonK191330Arc EnterocuffBoddingtons Plastics, 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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