510(k) K990349 ยท MQF Catheter, Assisted Reproduction
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
| Applicant | CooperSurgical, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Jul 26, 1999 |
| Received | Feb 5, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990349
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound)
Product Code: PE623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine ca Terminated |
MQF | None listed |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator
Product Code: PEB623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following Terminated |
MQF | None listed |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet
Product Code:PES623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in Terminated |
MQF | None listed |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator
PPB623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro Terminated |
MQF | None listed |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet
PPS623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity Terminated |
MQF | None listed |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Single Stage Embryo Replacement Catheter
Product Code: PP623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitr Terminated |
MQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.