510(k) K093665 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
ENDO SMARTCAP
| Applicant | Byrne Medical, Inc., Conroe TX, US |
| Decision | Substantially Equivalent, Dec 15, 2009 |
| Received | Nov 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2019 | Medivators, Inc. Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - P Terminated |
FAJ | None listed |
| Oct 9, 2019 | Medivators, Inc. Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile Terminated |
FAJ | None listed |
| Oct 9, 2019 | Medivators, Inc. Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Steri Terminated |
FAJ | None listed |
| Oct 9, 2019 | Medivators, Inc. Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes Wit Terminated |
FAJ | None listed |
| Oct 9, 2019 | Medivators, Inc. Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile Terminated |
FAJ | None listed |
| Oct 9, 2019 | Medivators, Inc. Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Cont Terminated |
FAJ | None listed |
| Oct 9, 2019 | Medivators, Inc. Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and s Terminated |
FAJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.