FDA 510(k) clearance · back to tracker

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Micro-Tech (Nanjing) Co., Ltd. cleared K261616 on 2026-10-15, decision: substantially equivalent

K-number

K261616

Sponsor

Micro-Tech (Nanjing) Co., Ltd.

Device

Single-Use EBUS Balloon

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-15

Product code

PSV

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K261616on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.