510(k) K093713 ยท ITX Transducer, Ultrasonic, Diagnostic
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
| Applicant | Civco Medical Instruments, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Jan 19, 2010 |
| Received | Dec 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2025 | Civco Medical Instruments Co. Inc. BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers Open, Classified |
ITX | None listed |
| Feb 23, 2018 | Civco Medical Instruments Co. Inc. CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Product Usage:
The bracket and disposable guide pro Terminated |
ITX | None listed |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided Terminated |
ITX | None listed |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, Terminated |
ITX | None listed |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 6 Terminated |
ITX | None listed |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Gui Terminated |
ITX | None listed |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.