HOPKINS Telescopes for Arthroscopy— 510(k) K254103
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K254103 for HOPKINS Telescopes for Arthroscopy, Substantially Equivalent on 2026-08-26. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
Karl Storz's HOPKINS Telescopes for Arthroscopy are filed under product code HRX, arthroscopes. The record gives no model numbers.
Class II, 21 CFR 888.1100. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Karl Storz filed from Tuttlingen, Germany. Review took 250 calendar days (December 19, 2025 to August 26, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Product code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code HRX
view allMore clearances from Karl Storz SE & CO. KG
view allAdverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.