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K-Systems Culture Bag Sealer and Culture Bags Type Cbs-1 and Cb-01

by K-Systems, Kivex Biotec, Ltd.

510(k) K013401

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 NumberK013401 Date14 Dec 2001ClearedStatusActive

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  • Withdrawn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
MQG
FDA applicant
K-Systems, Kivex Biotec , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.6120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent