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Medone MO20100-C0

by Medax Unipersonale Srl

Medone MO20100-C0 is a Class II device made by Medax Unipersonale Srl, cleared under FDA 510(k) K172344 on 13 Nov 2017 and listed in FDA GUDID since 6 Mar 2018 (UDI-DI 08053329372503), 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) K172344

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 Number08053329372503 UDI-DI Date6 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172344 Date13 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172344 decided 13 Nov 2017 Active
  • FDA GUDID UDI-DI 08053329372503 listed 6 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172344
  2. Listed FDA GUDID 08053329372503

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medone
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Model / reference
MO20100-C0
Primary DI / UDI-DI
08053329372503
510(k) Number
FDA product code
KNW
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Soft-tissue biopsy procedure kit, non-medicated

Cleared under the same submission (K172344)

and 8 more cleared under K172344

Similar devices in this category

Other devices filed under Soft-tissue biopsy procedure kit, non-medicated.

Other devices from Medax Unipersonale Srl

See all devices from Medax Unipersonale Srl →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)