INDIBA COMPACT devices

by Indiba S.A.U. Spain 510(k)

510(k) K243164

Product code PBX

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK243164	Date20 Nov 2024Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K243164
FDA Product Code: PBX
FDA applicant: Indiba S. A. U.

Device Class: Class II
Regulation: 21 CFR Part 878.4400
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

From the manufacturer

See how the INDIBA Compact devices can be used as a tool to improve patient and business outcomes in the latest on-demand webinar.

Source: indiba.com

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K243164 24 fields · synced 22 Oct 2026