510(k) K970514 ยท ITX Transducer, Ultrasonic, Diagnostic
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE
| Applicant | CIVCO Medical Instruments Co., Inc., Kalona IA, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | Feb 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2018 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO Terminated |
ITX | None listed |
| Jul 30, 2018 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO Terminated |
ITX | None listed |
| Mar 19, 2008 | Civco Medical Instruments Inc CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label sho Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.