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IPC Visao® 3318606E

by Medtronic Xomed Inc

IPC Visao® 3318606E is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K081277 on 5 Sep 2008 and listed in FDA GUDID since 2 May 2016 (UDI-DI 00613994436436), active as of 8 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K081277

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994436436 UDI-DI Date2 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081277 Date5 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081277 decided 5 Sep 2008 Active
  • FDA GUDID UDI-DI 00613994436436 listed 2 May 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0961-2022 FDA Class II initiated 15 Dec 2021

    As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

Timeline

3 dated events

  1. Cleared FDA 510(k) K081277
  2. Listed FDA GUDID 00613994436436
  3. Recall initiated FDA recalls Z-0961-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
IPC Visao®
Generic name
Surgical irrigation tubing set, single-use
Model / reference
3318606E
Primary DI / UDI-DI
00613994436436
510(k) Number
FDA product code
ERL
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class II
Regulation number
874.4250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation tubing set, single-use

Cleared under the same submission (K081277)

and 8 more cleared under K081277

Similar devices in this category

Other devices filed under Surgical irrigation tubing set, single-use.

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)