510(k) K920803 ยท HIB Speculum, Vaginal, Nonmetal
HSG TRAY
| Applicant | Unimar, Inc., Wilton CT, US |
| Decision | Unknown, Oct 19, 1992 |
| Received | Feb 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2025 | CooperSurgical, Inc. HSG Procedure Tray. Model Number: 6050T.
The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures. Open, Classified |
HIB | None listed |
| Jul 18, 2025 | CooperSurgical, Inc. Endosee System Convenience Kit. Model Number: ES-TRAY.
Endosee System Convenience Kit Open, Classified |
HIB | None listed |
| Jul 18, 2025 | CooperSurgical, Inc. Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV.
Endosee System Convenience Kit with IV Tube. Open, Classified |
HIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.