510(k) K123319 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
GYRUS ACMI BICOAG HEMOSTASIS PROBE
| Applicant | Olympus Surgical Technologies America, Southborough MA, US |
| Decision | Substantially Equivalent, Dec 14, 2012 |
| Received | Oct 26, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123319
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. Open, Classified |
KNS | None listed |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. Open, Classified |
KNS | None listed |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. Open, Classified |
KNS | None listed |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. Open, Classified |
KNS | None listed |
| Apr 5, 2024 | Olympus Corporation of the Americas Hemostasis Probe, Model: CD-B622LA Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.