THE ESPINER SAC OR E SAC— 510(k) K111845
Substantially EquivalentEspiner Medical Limited
FDA 510(k) clearance K111845 for THE ESPINER SAC OR E SAC, Substantially Equivalent on 2011-09-26. Applicant: Espiner Medical Limited. Device class: 2.
Clearance details
- Applicant
- Espiner Medical Limited
- 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
- Glasgow, GB
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)
Adverse 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 K111845
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 K111845.
Data sourced from openFDA. This site is unofficial and independent of the FDA.