HOPKINS Telescopes for Arthroscopy
FDA 510(k) K254103 · Karl Storz SE & CO. KG
510(k) numberK254103
Submission
- Device name
- HOPKINS Telescopes for Arthroscopy
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- December 19, 2025
- Decision date
- August 26, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code HRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
| K252594 | UltraGuideCTR® image guided soft tissue release systemHRX · Traditional | Sonex Health | 09/29/2025SE |
More from Sonex Health
| 510(k) | Device | Decision |
|---|---|---|
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | 09/01/2026SE |
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | 08/19/2026SE |
| K261706 | Endomat Select (UP220)HIG · Traditional | 07/16/2026SE |
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | 06/03/2026SE |
| K254228 | KARL STORZ Trocars with Valve SealsGCJ · Traditional | 05/11/2026SE |
| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | 03/02/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | 02/26/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | 02/12/2026SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | 12/05/2025SE |
| K250927 | KARL STORZ Cholangiography SetGCJ · Traditional | 11/22/2025SE |
Questions and answers
When was HOPKINS Telescopes for Arthroscopy cleared by the FDA?
HOPKINS Telescopes for Arthroscopy (K254103) received a 510(k) decision of Substantially Equivalent on August 26, 2026, 250 days after the submission was received.
What is the product code of K254103?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.