510(k) clearance
HOPKINS Telescopes for Arthroscopy
- 510(k) number
- K254103
- Applicant
- Karl Storz SE & CO. KG
- Decision date
- Aug 26, 2026
- Date received
- Dec 19, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HRX
- Device type
- Arthroscope
- Device class
- Class II
- Regulation
- 21 CFR 888.1100
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Tuttlingen, DE