Ilook 25 Needle Guide Attachment and Bracket Assembly

510(k) K030064

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

16 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK030064	Date22 Jan 2003Cleared	StatusActive

16 recalls · FDA

12 recalls, same reason
- Terminated Z-0566-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0569-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0575-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0565-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0574-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0572-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0567-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0573-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0568-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0576-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0571-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0570-2019 FDA Class II initiated 2 Nov 2018
3 recalls, same reason
- Terminated Z-0563-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0564-2019 FDA Class II initiated 2 Nov 2018
- Terminated Z-0562-2019 FDA Class II initiated 2 Nov 2018
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
- Terminated Z-0407-06 FDA Unclassified (pre-2012) initiated 12 Dec 2005
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.

1 jurisdiction

United States — FDA 510(k) Active

510(k)