K253020
- 510(k) number
- K253020
- Device name
- Strauss Surgical Resection Instruments
- Applicant
- American Medical Endoscopy, Inc. FL · US
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2026-06-04
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253020
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.