Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter— 510(k) K211806

Clearance details

Applicant

Venclose, Inc.

Product code

Product code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

2021-06-11

Decision date

2021-08-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

• K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)2026-10-26
• K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more2026-10-20
• K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)2026-09-17
• K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more2026-09-17
• K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated2026-09-15

• K252316 — Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)2025-08-19
• K250068 — Venclose digiRF Generator (VCRFG1)2025-02-04
• K160754 — Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)2016-09-09

Death

133

Injury

7,585

Malfunction

35,808

Other

44

Total

43,570

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 →

• Z-2638-2025 — Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).Class II·Ongoing·Bard Peripheral Vascular Inc·20250821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211806.