Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

K-Number: K193561 · 2020-04-15

ApplicantWeihai Xingtai Packaging Products Co., Ltd.
Decision Date2020-04-15
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Xingtai Packaging Products Co., Ltd.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K193561. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Weihai Xingtai Packaging Products Co., Ltd.. The 510(k) number is K193561.

When did Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch receive FDA 510(k) clearance?

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch received FDA 510(k) clearance on 2020-04-15, under 510(k) number K193561.

Who is the listed applicant for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

The FDA 510(k) record lists Weihai Xingtai Packaging Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

The FDA product code for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is FRG.

Other records listing Weihai Xingtai Packaging Products Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑