SMARTRELEASE Endoscopic Soft Tissue Release System
FDA 510(k) K211297 · Microaire Surgical Instruments
510(k) numberK211297
Submission
- Device name
- SMARTRELEASE Endoscopic Soft Tissue Release System
- Applicant
- Microaire Surgical Instruments
Charlottesville, VA, US - Received
- April 28, 2021
- Decision date
- June 24, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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).
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 |
|---|---|---|
| K243589 | PAL Sterilization CaseKCT · Traditional | 06/20/2025SE |
| K244026 | PAL 7020 ConsoleQPB · Traditional | 04/25/2025SE |
| K242804 | PAL Aspiration SystemQPB · Traditional | 12/30/2024SE |
| K223406 | SmartRelease Endoscopic Soft Tissue Release SystemHRX · Traditional | 02/02/2023SE |
| K220318 | PAL Infiltration SystemQPB · Traditional | 10/14/2022SE |
| K212024 | PAL SystemQPB · Traditional | 06/10/2022SE |
| K192694 | PAL Single-Use CannulasQPB · Traditional | 05/14/2020SE |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release SystemHRX · Traditional | 11/06/2018SE |
| K171286 | PAL Multi-Use Cannulas and PAL Manual WandQPB · Traditional | 10/13/2017SE |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU · Traditional | 05/22/2015SE |
Questions and answers
When was SMARTRELEASE Endoscopic Soft Tissue Release System cleared by the FDA?
SMARTRELEASE Endoscopic Soft Tissue Release System (K211297) received a 510(k) decision of Substantially Equivalent on June 24, 2021, 57 days after the submission was received.
What is the product code of K211297?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.