MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM— 510(k) K070712
Substantially EquivalentSurgical Innovations Group Plc
FDA 510(k) clearance K070712 for MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM, Substantially Equivalent on 2007-03-28. Applicant: Surgical Innovations Group Plc. Device class: 2.
Clearance details
- Applicant
- Surgical Innovations Group Plc
- 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
- Special
- Location
- Leeds, 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)
More clearances from Surgical Innovations Group Plc
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 K070712
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 K070712.
Data sourced from openFDA. This site is unofficial and independent of the FDA.