510(k) K945185 ยท FBO Cystourethroscope
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, May 3, 1995 |
| Received | Oct 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | Karl Storz Endoscopy CYSTO-URETHRO-FIBERSCOPE REF 11272C1
CYSTOSCOPE, 15FR X 370MM, ADULT
REF 11272C2 and Kit Number 11272CK2
CYSTO-URETHRO-FIBERSCOPE
REF 11272CU1 and Kit Number 11272CUK1 Open, Classified |
FBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.