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
- Product 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 allMore 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.