PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator— 510(k) K162362

Name: FDA 510(k) clearance K162362
Creator: U.S. Food and Drug Administration
Published: 2017-10-13

Substantially Equivalent

Pms Tibbi Cihazlar Teknolojisi San VE Tic AS

FDA 510(k) clearance K162362 for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, Substantially Equivalent on 2017-10-13. Applicant: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. Device class: 2.

Clearance details

Applicant: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2016-08-23
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mersin, TR

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRG

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K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more2026-07-02
K252823 — Dukal Crepe Paper Sterilization Wrap2026-05-28
K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
K251347 — Sterilization Pouch/Roll2026-01-28
K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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