YelloPort Elite Port Access System— 510(k) K190592
Substantially EquivalentSurgical Innovations Limited
FDA 510(k) clearance K190592 for YelloPort Elite Port Access System, Substantially Equivalent on 2019-04-29. 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 K190592
K-number listed on FDA's recall record- Z-1396-2022 — YelloPort Elite Universal Seal. For use in laparoscopic procedures.
- Z-1852-2022 — Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190592.
Data sourced from openFDA. This site is unofficial and independent of the FDA.