ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY— 510(k) K030064

Clearance details

Applicant

Sonosite,Inc.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2003-01-07

Decision date

2003-01-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bothell, WA, US

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• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K113156 — SONOSITE EDGE ULTRASOUND SYSTEM2011-11-15
• K110645 — BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR2011-06-03
• K102390 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM2010-11-19
• K093510 — LUMENVU CATHETER GUIDANCE SYSTEM2010-08-23
• K101757 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM2010-08-12

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0562-2019 — CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0563-2019 — SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0564-2019 — CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0565-2019 — CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0566-2019 — SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0567-2019 — SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0568-2019 — CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0569-2019 — CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0570-2019 — CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0571-2019 — CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0572-2019 — CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0573-2019 — CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0574-2019 — CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0575-2019 — CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102
• Z-0576-2019 — CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.Class II·Terminated·CIVCO Medical Instruments Co., Inc.·20181102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030064.