510(k) K150158 ยท HIH Hysteroscope (And Accessories)
Schoelly Cystoscopes/Hysteroscopes and Accessories
| Applicant | Schoelly Fiberoptic GmbH, Denzlingen, DE |
| Decision | Substantially Equivalent, Mar 9, 2015 |
| Received | Jan 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2023 | Scholly Fiberoptic Gmbh UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder.
Model: UL-VO Open, Classified |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.