510(k) K790071 ยท GCP Endoscope, Ac-Powered And Accessories
ENDOSCOPE AND ACCESSORIES
| Applicant | Olympus Corp., Walker MI, US |
| Decision | Substantially Equivalent, Apr 2, 1979 |
| Received | Jan 11, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2026 | Olympus Corporation of the Americas Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. Open, Classified |
GCP | None listed |
| Feb 20, 2026 | Olympus Corporation of the Americas Olympus Cystoscope Outer Sheath;
Model/Catalog number: WA22810A; Open, Classified |
GCP | None listed |
| Nov 8, 2024 | Olympus Corporation of the Americas Brand Name: Olympus
Product Name: Cystoscope Outer Sheath
Model/Catalog Number: WA22810A
Software Version: N/A
Product Description: Outer sheaths can be combined with rigid Telescopes.
Component: N/A Open, Classified |
GCP | None listed |
| Aug 18, 2017 | Olympus Corporation of the Americas A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W)
Product Usage:
A20975A: Working insert Terminated |
GCP | None listed |
| Apr 19, 2017 | Olympus Corporation of the Americas High Frequency Resection Electrodes, endoscope, ac-powered and accessories
The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications. Terminated |
GCP | None listed |
| Mar 18, 2010 | Olympus America Inc. Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L
Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscop Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.