Home / 510(k) Clearances / K230432

510(k) K230432

Single Use Bipolar Forceps by Hg Innovations, Ltd. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2023
Date Received
February 17, 2023
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 Hg Innovations, Ltd.

  • K233346 — Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cab (November 20, 2023)
  • K233351 — Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HN (November 20, 2023)

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)