Skip to content

Basic, Dominant Flex

by Modela AG

510(k) K170329

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK170329 Date24 Mar 2017ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1502-2021 FDA Class II initiated 2 Dec 2020 on shared 510(k) K170329

    Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
QPB
Device Class
Class II
Regulation
21 CFR Part 878.5040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent