# K211297: SMARTRELEASE Endoscopic Soft Tissue Release System

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments
- Decided: Jun 24, 2021 after 57 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K844002 (1984). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181819: SMARTRELEASE Endoscopic Soft Tissue Release System, Microaire Surgical Instruments, LLC (2018) Summary page 4.
- K080133: Mountable Endoscopic Blade, A.M. Surgical, Inc. (2008) Summary page 4.

## Indications for use
The SMARTRELEASE® Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release: • Carpal tunnel release in the wrist • Cubital tunnel release in the elbow • Plantar fascia release in the foot • Gastrocnemius aponeurosis recession in the leg

Source page: https://510kreport.com/device/K211297
Methodology: https://510kreport.com/methodology