510(k) K962482 ยท HIH Hysteroscope (And Accessories)
SCUBA SYSTEM
| Applicant | Gynecare, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Nov 1, 1996 |
| Received | Jun 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962482
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2005 | Ethicon, Inc VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville Terminated |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.