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CureOs TCP

by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic

510(k) K191670

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 NumberK191670 Date4 Aug 2020ClearedStatusActive

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  • Withdrawn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
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

CureOs TCP is a medical device classified under the Orthopedic advisory committee. It received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device is manufactured by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic. Its 510(k) number is K191670, product code is MQV, and it was cleared on August 4, 2020, following a traditional review process.