U-IGNITE Bladeless Trocar

by Tianjin Uwell Medical Device Manufacturing Co., Ltd. China 510(k)

510(k) K162387

Product code GCJ

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK162387	Date11 Jan 2017Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K162387
FDA Product Code: GCJ

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K162387 24 fields · synced 22 Oct 2026