C-Lant Port— 510(k) K252714

Name: FDA 510(k) clearance K252714
Creator: U.S. Food and Drug Administration
Published: 2026-02-27

Substantially Equivalent

Vigor Medical Technologies , Ltd.

FDA 510(k) clearance K252714 for C-Lant Port, Substantially Equivalent on 2026-02-27. Applicant: Vigor Medical Technologies , Ltd.. Device class: 2.

Summary

Vigor Medical Technologies' C-Lant Port is filed under product code GCJ (Laparoscope, General & Plastic Surgery). The name is short, and the record doesn't describe the device beyond it and that code name.

Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel.

Vigor Medical Technologies filed from Haifa, Israel. The substantially equivalent decision came 184 calendar days after receipt (August 27, 2025 to February 27, 2026).

Clearance details

Applicant: Vigor Medical Technologies , Ltd.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-27
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCJ

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K262455 — da Vinci 5 Handheld Camera Head (470080) +4 more2026-10-14
K262397 — CuratOR EX27422026-09-11
K260884 — UNIDRIVE Select System2026-09-01
K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor2026-08-26

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.