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CTS Relief Kit

by Linvatec Corp.

510(k) K941651

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 NumberK941651 Date18 Jan 1995ClearedStatusActive

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 CTS Relief Kit is a surgical device kit designed for the treatment of carpal tunnel syndrome. It is classified under the orthopedic product code and is intended for use in releasing the transverse carpal ligament to relieve pressure on the median nerve.

The device is supplied as a single-use kit and is intended for sterile surgical use. It is regulated under FDA 510(k) premarket notification with the reference number K941651, and was authorized for marketing on January 18, 1995. The kit is distributed by Linvatec Corp. and is stored in accordance with standard medical device handling procedures.

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