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Diego 70138019

by Gyrus Acmi, Inc.

Diego 70138019 is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K020594 on 8 Mar 2002 and listed in FDA GUDID since 12 Sep 2018 (UDI-DI 00821925025578), 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) K020594

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 Number00821925025578 UDI-DI Date12 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020594 Date8 Mar 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020594 decided 8 Mar 2002 Active
  • FDA GUDID UDI-DI 00821925025578 listed 12 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020594
  2. Listed FDA GUDID 00821925025578

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diego
Generic name
Electrosurgical handpiece, reusable
Model / reference
70138019
Primary DI / UDI-DI
00821925025578
510(k) Number
FDA product code
ERL
GMDN term
Electrosurgical handpiece, reusable
Device class
Class II
Regulation number
874.4250
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under Electrosurgical handpiece, reusable.

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Properties

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