Flexmedics Malleable Cannula
FDA 510(k) K910674 · Flexmedics
510(k) numberK910674
Submission
- Device name
- Flexmedics Malleable Cannula
- Applicant
- Flexmedics
Minneapolis, MN, US - Received
- February 15, 1991
- Decision date
- April 12, 1991
- 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).
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 |
|---|---|---|
| K990765 | Flexfinder Guide Wire(Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire…OCY · Special | 03/15/1999SE |
| K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…OCY · Traditional | 02/14/1997SE |
| K952430 | Finesse Guidewire CoronaryDQX · Traditional | 08/18/1995SE |
| K943390 | Flexfinder GuidewireDQX · Traditional | 06/27/1995SE |
| K942074 | Flexfinder GuidewireKNY · Traditional | 06/24/1994SE |
| K934265 | Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireDZC · Traditional | 01/21/1994SE |
| K912843 | Flexmedics Retract Orth Probe, Pettine Bone ProbeHXB · Traditional | 09/24/1991SE |
| K895899 | Flexmedics Guidewire .012 OnlyDQX · Traditional | 05/23/1990SE |
| K893626 | Flexmedics GuidewireDQX · Traditional | 09/26/1989SE |
| K885086 | Tin Coated Niti Orthodontic Arch WiresEJF · Traditional | 01/10/1989SE |
Questions and answers
When was Flexmedics Malleable Cannula cleared by the FDA?
Flexmedics Malleable Cannula (K910674) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 56 days after the submission was received.
What is the product code of K910674?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.