Port Access System— 510(k) K210495
Substantially EquivalentSurgical Innovations Limited
FDA 510(k) clearance K210495 for Port Access System, Substantially Equivalent on 2021-06-18. Applicant: Surgical Innovations Limited. Device class: 2.
Clearance details
- Applicant
- Surgical Innovations 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
- 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 Limited
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 K210495
K-number listed on FDA's recall record- Z-1601-2023 — YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
- Z-1602-2023 — YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210495.
Data sourced from openFDA. This site is unofficial and independent of the FDA.