510(k) K070915 ยท KDM Sigmoidoscope, Rigid, Non-Electrical
SAPIMED DISPOSABLE SIGMOIDOSCOPE
| Applicant | Sapimed S.P.A., Crofton MD, US |
| Decision | Substantially Equivalent, Jul 6, 2007 |
| Received | Apr 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070915
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2021 | Adler MicroMed, Inc. Sapi Med sterile disposable colorectal anoscopes and proctoscopes.
REF/Product Description:
A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light;
A.4519/MPR Short - Terminated |
KDM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.