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)

Perpak™ Sterilization Tyvek Pouch

K-Number: K241123 · 2024-09-18

ApplicantKm Corp.
Decision Date2024-09-18
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Perpak™ Sterilization Tyvek Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Km Corp.. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K241123. 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 Perpak™ Sterilization Tyvek Pouch?

Perpak™ Sterilization Tyvek Pouch is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Km Corp.. The 510(k) number is K241123.

When did Perpak™ Sterilization Tyvek Pouch receive FDA 510(k) clearance?

Perpak™ Sterilization Tyvek Pouch received FDA 510(k) clearance on 2024-09-18, under 510(k) number K241123.

Who is the listed applicant for Perpak™ Sterilization Tyvek Pouch?

The FDA 510(k) record lists Km Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perpak™ Sterilization Tyvek Pouch?

The FDA product code for Perpak™ Sterilization Tyvek Pouch is FRG.

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.

↑