Arthroscopic Surgery Blades DY-3440, 3443, 3444
FDA 510(k) K901735 · Micro-Aire Surgical Instruments, Inc.
510(k) numberK901735
Submission
- Device name
- Arthroscopic Surgery Blades DY-3440, 3443, 3444
- Applicant
- Micro-Aire Surgical Instruments, Inc.
Valencia, CA, US - Received
- April 17, 1990
- Decision date
- June 20, 1990
- 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 |
|---|---|---|
| K904949 | A.O. Synthes,Tap(Replacement)Various Model NumbersHSZ · Traditional | 11/26/1990SE |
| K903713 | Osteotome Model Numbers 2500-228 & 2500-229HSZ · Traditional | 09/14/1990SE |
| K903650 | Oscillating Saw Blades # SO-305,MO-305 and ZO-305HWE · Traditional | 09/14/1990SE |
| K902676 | Microguard, Orthopedic Pin ProtectorsLYT · Traditional | 09/14/1990SE |
| K903664 | Micro-Aire Wire Pass and Craniotome DrillHBE · Traditional | 09/13/1990SE |
| K901967 | Dendia Werk Burs and Cutting DiscsDZP · Traditional | 07/13/1990SE |
| K902168 | Arthroscopic Surgery Blades (Several Models)HRX · Traditional | 06/20/1990SE |
| K900033 | Micro-Aire Powered Micro-Surgery InstrumentsGEY · Traditional | 02/13/1990SE |
| K900210 | Bone Harvester System & Osteotome System 2500HSZ · Traditional | 02/02/1990SE |
| K896280 | Micro-Aire Oscillating Saw Blade 202C-25, 202C-50GFA · Traditional | 11/22/1989SE |
Questions and answers
When was Arthroscopic Surgery Blades DY-3440, 3443, 3444 cleared by the FDA?
Arthroscopic Surgery Blades DY-3440, 3443, 3444 (K901735) received a 510(k) decision of Substantially Equivalent on June 20, 1990, 64 days after the submission was received.
What is the product code of K901735?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.