K223885
- 510(k) number
- K223885
- Device name
- HOPKINS Telescopes
- Applicant
- Karl Storz Endoscopy America, Inc. CA · US
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2023-09-14
- Date received
- 2022-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K223885.pdf
Official FDA record: K223885
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.