I.M. Arthroscope
FDA 510(k) K821847 · Instrument Makar, Inc.
510(k) numberK821847
Submission
- Device name
- I.M. Arthroscope
- Applicant
- Instrument Makar, Inc.
Mchenry, IL, US - Received
- June 22, 1982
- Decision date
- July 22, 1982
- Decision
- Substantially Equivalent (SESE)
- 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).
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|---|---|---|---|
| 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 |
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| K963396 | Biosphere Suture AnchorMAI · Traditional | 05/06/1997SE |
| K964364 | Disposable ApronLYU · Traditional | 02/25/1997SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | 11/19/1996SE |
| K960555 | Bioasbsorbable Mini-Screw Suture AnchorMAI · Traditional | 07/09/1996SE |
| K943249 | Bioabsorbable Interference ScrewMAI · Traditional | 07/31/1995SE |
| K944062 | Laprascopic GrasperGCS · Traditional | 02/23/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
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Questions and answers
When was I.M. Arthroscope cleared by the FDA?
I.M. Arthroscope (K821847) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 30 days after the submission was received.
What is the product code of K821847?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.