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The Tracker / October 2026 / K261616

510(k) cleared

Single-Use EBUS Balloon

Micro-Tech (Nanjing) Co., Ltd. · Oct 15, 2026 · K261616

FDA cleared the Single-Use EBUS Balloon from Micro-Tech (Nanjing) Co., Ltd. on Oct 15, 2026 under K261616, a traditional 510(k). The device falls under product code PSV, Ultrasound Bronchoscope, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 15, 2026. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Micro-Tech (Nanjing) Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252492 (Visualized Access and Delivery Catheter; PB Digital Controller), K251692 (Advanced Tissue Resection Device).

Questions & Answers

What did FDA clear under K261616?

K261616 is the FDA 510(k) for Single-Use EBUS Balloon, submitted by Micro-Tech (Nanjing) Co., Ltd.. FDA's decision date was Oct 15, 2026, under product code PSV (Ultrasound Bronchoscope).

Who makes the Single-Use EBUS Balloon?

Micro-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K261616.

How long did the K261616 review take?

FDA received the submission on May 15, 2026 and issued its decision on Oct 15, 2026, 153 days later.

← All decisions in October 2026

Sources