UNIMAX SPECIMEN RETRIEVAL SYSTEM— 510(k) K103510
Substantially EquivalentUnimax Medical Systems, Inc.
FDA 510(k) clearance K103510 for UNIMAX SPECIMEN RETRIEVAL SYSTEM, Substantially Equivalent on 2011-05-06. Applicant: Unimax Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Unimax Medical Systems, Inc.
- 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
- Taipei County, TW
Recent devices under product code GCJ
view all- K262397 — CuratOR EX2742
- 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 Unimax Medical Systems, Inc.
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 →
Recalls naming K103510
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103510.
Data sourced from openFDA. This site is unofficial and independent of the FDA.