STERIKING STERILIZATION POUCHES & ROLLS— 510(k) K953776

Name: FDA 510(k) clearance K953776
Creator: U.S. Food and Drug Administration
Published: 1995-10-12

Substantially Equivalent

Wihuri OY

FDA 510(k) clearance K953776 for STERIKING STERILIZATION POUCHES & ROLLS, Substantially Equivalent on 1995-10-12. Applicant: Wihuri OY. Device class: 2.

Clearance details

Applicant: Wihuri OY
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1995-08-11
Decision date: 1995-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

view all

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K253187 — SteriBest® Sterilization Tray System2026-06-18
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.