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510(k) K211806

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter by Venclose, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2021
Date Received
June 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Venclose, Inc.

  • K252316 — Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A2 (August 19, 2025)
  • K250068 — Venclose digiRF Generator (VCRFG1) (February 4, 2025)
  • K160754 — Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) (September 9, 2016)

Other clearances for product code GEI

  • K253917 — ARION ARC System (April 10, 2026)
  • K253777 — Ascblue (8010) (April 10, 2026)
  • K260466 — Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional (April 7, 2026)
  • K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (April 6, 2026)
  • K253405 — Prana System (April 1, 2026)
  • K254122 — FLOW FLEXTEND Wand (72290039) (March 30, 2026)
  • K260255 — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (March 27, 2026)
  • K253680 — LYNX COBLATION Laryngeal Wand (72290254) (March 25, 2026)
  • K253750 — BTL-785NEH (March 17, 2026)
  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)