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Tristel OPH

by Tristel Solutions Limited United Kingdom 510(k)

510(k) K242732

Product code QWS

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242732 Date9 May 2025ClearedStatusActive

Coverage

1 jurisdiction

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  • 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
FDA Product Code
QWS
FDA applicant
Tristel Solutions , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.6886
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K242732 24 fields · synced 22 Oct 2026