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Needle Guide Starter Kit 674-052

by Civco Medical Instruments Co., Inc. EUDAMEDGUDID

Active European Union and United States

Ref P27068-01, P12051-02, P01300-08, 674-031-T, P18708-01, P15679-01, P07873-02, P28645-01, P28664-01, P04999-04, P01882-08, 674-037, P12868-03, P28662-01, 671-002, P28775-01, P28643-01, 674-038, 680-186, 674-031, P27066-01, P18710-01, 693-013, 674-035, 693-011

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD101C1ND Basic UDI-DIDate16 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841436118620 UDI-DIDate22 Aug 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

23 recalls · 1 ongoing · FDA

    • Ongoing Z-1892-2025 FDA Class II initiated 1 May 2025

    During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

  • 12 recalls, same reason

    • Terminated Z-0575-2019 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
    • Terminated Z-0566-2019 FDA Class II initiated 2 Nov 2018
    • Terminated Z-0569-2019 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

  • 3 recalls, same reason

    • Terminated Z-0562-2019 FDA Class II initiated 2 Nov 2018
    • Terminated Z-0563-2019 FDA Class II initiated 2 Nov 2018
    • Terminated Z-0564-2019 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-2888-2018 FDA Class II initiated 23 Feb 2018

    A cover failed leak testing during validation testing of new needle guides from a replacement tool.

  • 5 recalls, same reason

    • Terminated Z-0288-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0289-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0286-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0287-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0290-2016 FDA Class II initiated 21 Oct 2015

    Sterility of the product cannot be assured.

    • 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.

Specification

EUDAMED · GUDID

Trade Name
Needle Guide Starter Kit
Generic Name
Ultrasound imaging system tracking positioner, reusable
Device Name
General Purpose Guidance – In-Plane, Open Channel (Infiniti plus guide)
General Purpose Guidance – In-Plane, Fixed Angle (Ultra-Pro II guide)
General Purpose Guidance – Out-of-Plane, Fixed Angle (L25 guide)
General Purpose Guidance – Out-of-Plane, Fixed Angle (Accusite guide)
Model / Ref / Catalog
P27068-01, P28662-01, P04999-04, P28664-01, P15679-01, 680-186, P12051-02, 693-011, P12868-03, 671-002, P01300-08, P28645-01, P27066-01, P07873-02, P18708-01, P28643-01, P28775-01, 674-038, P18710-01, 674-031, 674-037, 674-035, P01882-08, 674-031-T, 693-013, 674-052
Description
Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CIV-Flex™ covers (5) for use with SonoSite
Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CIV-Flex™ covers (5) for use with SonoSite
Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with SonoSite
Reusable non-sterile single-angle bracket with AccuSITE™ needle guides (5) and (14 × 147cm) CIV-Flex™ covers (5) for use with EchoNous Vein transducers
Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with SonoSite
Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guide (5), (14 x 147cm) CIV-Flex™ covers (5) for use with SonoSite
Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CIV-Flex™ covers (5) for use with FUJIFILM SonoSite
Primary DI / UDI-DI
00841436118620, 00841436120807, 00841436109956, 00841436120814, 00841436110136, 00841436124317, 00841436110082, 00841436122597, 00841436113731, 00841436114288, 00841436109901, 00841436120791, 00841436120371, 00841436110044, 00841436110143, 00841436120784, 00841436120838, 00841436107020, 00841436110150, 00841436106979, 00841436107013, 00841436106993, 00841436109925, 00841436106986, 00841436122627, 00841436107143
Basic UDI-DI
0841436101TD101C1ND, 0841436101TD101A3NB, 0841436101TD101B2NC, 0841436101TD101B1NA
Direct Marketing DI
20841436118853
20841436116422
20841436116408
20841436117351
20841436115821
20841436115999
20841436117344
20841436116101
20841436117061
20841436115647
20841436115333
20841436116095
20841436116064
20841436116415
20841436116651
20841436120856
20841436120368
20841436116194
20841436122614
20841436122584
510(k) Number
FDA Product Code
ITX
EMDN Code
A018002 Needle guides
GMDN Term
Ultrasound imaging system tracking positioner, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Size
Length — 3.8 Inch
Width — 1.4 Inch
Width — 1.49 Inch
Length — 1.97 Inch
Length — 3.91 Inch
Height — 2.05 Inch
Width — 1.25 Inch
Length — 3.84 Inch
Height — 1.9 Inch
Length — 3.3 Inch
Length — 14 Centimeter
Width — 147 Centimeter
Length — 3.76 Inch
Height — 1.15 Inch
Length — 1.99 Inch
Width — 1.46 Inch
Length — 2.85 Inch
Height — 2.07 Inch
Length — 1.8 Inch
Width — 1.2 Inch
Height — 1.89 Inch
Length — 3.77 Inch
Height — 1.3 Inch
Length — 3.2 Inch
Height — 1.2 Inch
Width — 1.58 Inch
Length — 4.12 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ultrasound imaging system tracking positioner, reusable

Cleared under the same submission (K093713)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No