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FDA 510(k)

Single-Use EBUS Balloon

K-Number: K261616 · 2026-10-15

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2026-10-15
Product CodePSV
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Single-Use EBUS Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K261616. The device is classified under product code PSV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-Use EBUS Balloon?

Single-Use EBUS Balloon is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K261616.

When did Single-Use EBUS Balloon receive FDA 510(k) clearance?

Single-Use EBUS Balloon received FDA 510(k) clearance on 2026-10-15, under 510(k) number K261616.

Who is the listed applicant for Single-Use EBUS Balloon?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use EBUS Balloon?

The FDA product code for Single-Use EBUS Balloon is PSV.

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Related Devices (Code: PSV)

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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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