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mi-eye 3 T300-160

by Trice Medical, Inc.

mi-eye 3 T300-160 is a Class II device made by Trice Medical, Inc., cleared under FDA 510(k) K212556 on 15 Sep 2021 and listed in FDA GUDID since 9 Dec 2022 (UDI-DI 00857356008293), active as of 22 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 22 Oct 2026

Documents

510(k) K212556

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857356008293 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK212556 Date15 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212556 decided 15 Sep 2021 Active
  • FDA GUDID UDI-DI 00857356008293 listed 9 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212556
  2. Listed FDA GUDID 00857356008293

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
mi-eye 3
Generic name
Rigid optical arthroscope, single-use
Model / reference
T300-160
Primary DI / UDI-DI
00857356008293
510(k) Number
FDA product code
HRX
GMDN term
Rigid optical arthroscope, single-use
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical arthroscope, single-use

Cleared under the same submission (K212556)

and 3 more cleared under K212556

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Trice Medical, Inc.

See all devices from Trice Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)