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MicroAire® 81025

by MicroAire Surgical Instruments LLC

MicroAire® 81025 is a Class II device made by MicroAire Surgical Instruments LLC, cleared under FDA 510(k) K223406 on 2 Feb 2023 (1 earlier submission) and listed in FDA GUDID since 17 Mar 2023 (UDI-DI 00847399017253), 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

1 ongoing

Recall on shared 510(k) K223406; other models may be affected

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847399017253 UDI-DI Date17 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223406 Date2 Feb 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223406 decided 2 Feb 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00847399017253 listed 17 Mar 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1975-2025 FDA Class II initiated 7 May 2025 on shared 510(k) K223406

    Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K080560
  2. Cleared FDA 510(k) K223406
  3. Listed FDA GUDID 00847399017253
  4. Recall initiated FDA recalls Z-1975-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MicroAire®
Generic name
Rigid optical arthroscope, reusable
Model / reference
81025
Primary DI / UDI-DI
00847399017253
510(k) Number
FDA product code
HRX
GMDN term
Rigid optical arthroscope, reusable
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid optical arthroscope, reusable

Cleared under the same submission (K080560)

and 8 more cleared under K080560

Cleared under the same submission (K223406)

Similar devices in this category

Other devices filed under Rigid optical arthroscope, reusable.

Other devices from MicroAire Surgical Instruments LLC

See all devices from MicroAire Surgical Instruments LLC →

Properties

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