Single-Use EBUS Balloon— 510(k) K261616

Name: FDA 510(k) clearance K261616
Creator: U.S. Food and Drug Administration
Published: 2026-10-15

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K261616 for Single-Use EBUS Balloon, Substantially Equivalent on 2026-10-15. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Product code PSV
Device class: Class 2
Regulation: 21 CFR 892.1550
Advisory panel: Radiology
Date received: 2026-05-15
Decision date: 2026-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSV

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K243471 — Extraction Basket2024-12-16

Adverse events under product code PSV

product code PSV

Death: 6
Injury: 305
Malfunction: 3,705
Total: 4,016

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.