Cleared Traditional

C-Lant Port

K252714 · Vigor Medical Technologies , Ltd. · General & Plastic Surgery
Feb 2026
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K252714 is an FDA 510(k) clearance for the C-Lant Port, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Vigor Medical Technologies , Ltd. (Haifa, IL). The FDA issued a Cleared decision on February 27, 2026, 184 days after receiving the submission on August 27, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K252714 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2025
Decision Date February 27, 2026
Days to Decision 184 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GCJ — Laparoscope, General & Plastic Surgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

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