Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch— 510(k) K193561

Name: FDA 510(k) clearance K193561
Creator: U.S. Food and Drug Administration
Published: 2020-04-15

Substantially Equivalent

Weihai Xingtai Packaging Products Co., Ltd.

FDA 510(k) clearance K193561 for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch, Substantially Equivalent on 2020-04-15. Applicant: Weihai Xingtai Packaging Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Weihai Xingtai Packaging Products Co., Ltd.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2019-12-23
Decision date: 2020-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Weihai, CN

Download summary PDF View on FDA.gov ↗

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K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
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K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

More clearances from Weihai Xingtai Packaging Products Co., Ltd.

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K183356 — Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch2019-08-19

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.