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Axon J1020

by Axon Medical

Axon J1020 is a Class II device made by Axon Medical, cleared under FDA 510(k) K811820 on 28 Jul 1981 and listed in FDA GUDID since 20 Jul 2016 (UDI-DI 00841019109298), 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) K811820

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 Number00841019109298 UDI-DI Date20 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK811820 Date28 Jul 1981DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K811820 decided 28 Jul 1981 Active
  • FDA GUDID UDI-DI 00841019109298 listed 20 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K811820
  2. Listed FDA GUDID 00841019109298

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Axon
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Model / reference
J1020
Primary DI / UDI-DI
00841019109298
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 8.5 Inch

Other devices from Axon Medical

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    Class II
  • Axon RAY-51

    Class II
  • Axon RAY-03

    Class II
  • Axon J2075

    Class II

See all devices from Axon Medical →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)