# K102219: Socorro Smi Tunnel Release Device

- Pathway: 510(k) (Traditional)
- Applicant: Socorro Medical, Inc.
- Decided: Sep 24, 2010 after 49 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982142 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080133: Mountable Endoscopic Blade, A.M. Surgical, Inc. (2008) Summary page 1.

## Indications for use
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in: -Plantar Fasciotomy, -Carpal Tunnel Release, -Elbow Cubital Tunnel Release and -Gastrocnemius Tenotomy.

Source page: https://510kreport.com/device/K102219
Methodology: https://510kreport.com/methodology
