Skip to content

RN Handpiece

by Hironic Co., Ltd.

RN Handpiece is a Class II device made by Hironic Co., Ltd., cleared under FDA 510(k) K233123 on 24 Jun 2024 and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 08800016273120), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K233123

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800016273120 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233123 Date24 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233123 decided 24 Jun 2024 Active
  • FDA GUDID UDI-DI 08800016273120 listed 15 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233123
  2. Listed FDA GUDID 08800016273120

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Electrosurgical system
Model / reference
RN Handpiece
Primary DI / UDI-DI
08800016273120
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233123)

and 8 more cleared under K233123

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Hironic Co., Ltd.

See all devices from Hironic Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)