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Euromi 1214L3GI-3150

by Euromi

Euromi 1214L3GI-3150 is a Class I device made by Euromi, cleared under FDA 510(k) K010311 on 29 Jun 2001 and listed in FDA GUDID since 10 Oct 2025 (UDI-DI 03701416202763), 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) K010311

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 Number03701416202763 UDI-DI Date10 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010311 Date29 Jun 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010311 decided 29 Jun 2001 Active
  • FDA GUDID UDI-DI 03701416202763 listed 10 Oct 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010311
  2. Listed FDA GUDID 03701416202763

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Euromi
Generic name
Liposuction system cannula, reusable
Model / Ref / Catalog
1214L3GI-3150
Primary DI / UDI-DI
03701416202763
510(k) Number
FDA product code
GEA
GMDN term
Liposuction system cannula, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K010311)

and 3 more cleared under K010311

Other devices from Euromi

See all devices from Euromi →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)