510(k) Report

FDA applicant

Venclose, Inc.

San Jose, CA4 decisions2016–20252 recalls

FDA records 4 decisions for Venclose, Inc. (San Jose, CA) from 2016 to 2025: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 39 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Venclose, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2016: 12021: 12025: 2
2016high 2 (2025) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024: 12025: 1
2016high 1 (2024) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Venclose, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Venclose, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 39 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 20163cite it
  • K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 20251cites it
  • K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose…Venclose, Inc. · 20211cites it

What has FDA decided for it lately?

  • K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc. · 2025
  • K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 20251 recall
  • K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose…Venclose, Inc. · 20211 recall
  • K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 20162 recalls

All 4 as Venclose, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K160754Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify…Aug 21, 2025Class II
  • K160754The EVSRF catheter is a sterile, single-use disposable medical device for endovenous…Sep 4, 2024Class II