Citscope, Bendable -- Modification
FDA 510(k) K924494 · Citation Medical Corp.
510(k) numberK924494
Submission
- Device name
- Citscope, Bendable -- Modification
- Applicant
- Citation Medical Corp.
Reno, NV, US - Received
- August 27, 1992
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| 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 |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951941 | Citation Multiple Use Delta ScopeHRX · Traditional | 07/14/1995SE |
| K945390 | Citation Delta ScopeHRX · Traditional | 06/23/1995SE |
| K946290 | Citation Power ToolHRX · Traditional | 06/15/1995SE |
| K951249 | Citation SinuscopeEOB · Traditional | 04/10/1995SE |
| K944976 | Bronchoscope,Non-RigidEOQ · Traditional | 12/21/1994SE |
| K940847 | Endoscopic Plantar Fascia KitHRX · Traditional | 10/11/1994SE |
| K941563 | The Biopsy ToolFCG · Traditional | 09/26/1994SE |
| K922144 | Citscope (Model Extensions)HRX · Traditional | 08/05/1992SE |
| K921692 | Integrated Video SystemHRX · Traditional | 07/01/1992SE |
| K912490 | Citation Medical Scope Procedure PackKKX · Traditional | 08/16/1991SE |
Questions and answers
When was Citscope, Bendable -- Modification cleared by the FDA?
Citscope, Bendable -- Modification (K924494) received a 510(k) decision of Substantially Equivalent for Some Indications on May 26, 1993, 272 days after the submission was received.
What is the product code of K924494?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.