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ColActive Plus

by Covalon Technologies Inc.

510(k) K260652

ColActive Plus is a device classified as Unclassified made by Covalon Technologies Inc., cleared under FDA 510(k) K260652 on 9 Sep 2026, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK260652 Date9 Sep 2026ClearedStatusActive

Official records

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  • Withdrawn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
KGN
FDA applicant
Covalon Technologies, Ltd.
Device class
U
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent