510(k) K013721 ยท ITX Transducer, Ultrasonic, Diagnostic
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
| Applicant | CIVCO Medical Instruments Co., Inc., Kalona IA, US |
| Decision | Substantially Equivalent, Dec 28, 2001 |
| Received | Nov 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2015 | Civco Medical Instruments Inc CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessor Terminated |
ITX | None listed |
| Mar 8, 2011 | Civco Medical Instruments Inc CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA. Terminated |
ITX | None listed |
| Aug 20, 2010 | Civco Medical Instruments Inc CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cov Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.