UNIMICRO SUCTION IRRIATION TUBING SET— 510(k) K141592
Substantially EquivalentUnimicro Medical Systems (Shenzhen) Co., Ltd.
FDA 510(k) clearance K141592 for UNIMICRO SUCTION IRRIATION TUBING SET, Substantially Equivalent on 2014-08-04. Applicant: Unimicro Medical Systems (Shenzhen) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Unimicro Medical Systems (Shenzhen) Co., Ltd.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, Guangdong, CN
Recent devices under product code GCJ
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- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Unimicro Medical Systems (Shenzhen) Co., Ltd.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . 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.