CareGUARD Sterilization Wrap— 510(k) K213907

Name: FDA 510(k) clearance K213907
Creator: U.S. Food and Drug Administration
Published: 2022-03-14

Substantially Equivalent

Care Essentials Pty, Ltd.

FDA 510(k) clearance K213907 for CareGUARD Sterilization Wrap, Substantially Equivalent on 2022-03-14. Applicant: Care Essentials Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Care Essentials Pty, Ltd.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2021-12-14
Decision date: 2022-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Geelong, AU

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

More clearances from Care Essentials Pty, Ltd.

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K232502 — Cocoon Convective Warming System, Model CWS70002024-02-21
K181671 — Cocoon Convective Warming System2019-05-02
K140635 — COCOON CONVECTIVE WARMING SYSTEM2014-07-25

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.