Endoscopic Plantar Fascia Kit
FDA 510(k) K940847 · Citation Medical Corp.
510(k) numberK940847
Submission
- Device name
- Endoscopic Plantar Fascia Kit
- Applicant
- Citation Medical Corp.
Reno, NV, US - Received
- February 23, 1994
- Decision date
- October 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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).
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| 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 |
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| K951941 | Citation Multiple Use Delta ScopeHRX · Traditional | 07/14/1995SE |
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| K946290 | Citation Power ToolHRX · Traditional | 06/15/1995SE |
| K951249 | Citation SinuscopeEOB · Traditional | 04/10/1995SE |
| K944976 | Bronchoscope,Non-RigidEOQ · Traditional | 12/21/1994SE |
| K941563 | The Biopsy ToolFCG · Traditional | 09/26/1994SE |
| K924494 | Citscope, Bendable -- ModificationHRX · Traditional | 05/26/1993SN |
| 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 Endoscopic Plantar Fascia Kit cleared by the FDA?
Endoscopic Plantar Fascia Kit (K940847) received a 510(k) decision of Substantially Equivalent on October 11, 1994, 230 days after the submission was received.
What is the product code of K940847?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.