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510(k) K030064 · ITX Transducer, Ultrasonic, Diagnostic

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY

Applicant	Sonosite,Inc., Bothell WA, US
Decision	Substantially Equivalent, Jan 22, 2003
Received	Jan 7, 2003
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K030064

Date	Firm and product	Code	Linked 510(k)
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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. Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA. Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers. Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for: Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 (( Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 wi Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 wi Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 seri Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 transdu Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. 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 transd Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx. Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx. Terminated	ITX	None listed
Nov 2, 2018	CIVCO Medical Instruments Co., Inc. CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives. Terminated	ITX	None listed
Jan 19, 2006	Sonosite, Inc. SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white back Terminated	ITX	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.