FDA 510(k)

Balloon BS-3

K-Number: K213195 · 2021-10-29

Decision Date2021-10-29

Product CodeFDA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Balloon BS-3 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2021-10-29 under approval 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. It is manufactured by Fujifilm Corporation. The 510(k) number is K213195.

When was Balloon BS-3 approved by the FDA?

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

What company makes Balloon BS-3?

Balloon BS-3 is manufactured by Fujifilm Corporation.

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)

K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd. K231323Ancora-SBAspero Medical, Inc. K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation

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.