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Socorro SMI Tunnel Release Device

by Socorro Medical, Inc.

510(k) K102219

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102219 Date24 Sep 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Socorro SMI Tunnel Release Device is a single-use, sterile surgical instrument designed for minimally invasive procedures. It consists of a handpiece with a tissue-cutting probe, used alongside an endoscope camera and fiber optic illumination system.

It 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. The device is supplied sterile and for single use only. It received FDA 510(k) clearance (K102219) on September 24, 2010, and is classified under product code GCJ.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Socorro SMI Tunnel Release Device used for?

    It 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, used alongside an endoscope camera and fiber optic illumination system.

  • Is the Socorro SMI Tunnel Release Device sterile and single-use?

    Yes, the device is supplied sterile and is designed for single use only, meaning it should not be reprocessed or reused after a procedure to maintain sterility and patient safety.

  • What regulatory pathway was used for the Socorro SMI Tunnel Release Device?

    The device received FDA 510(k) clearance (K102219) on September 24, 2010, and was found substantially equivalent to a predicate device, which is the regulatory route for moderate-risk medical devices in the United States.