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FDA 510(k)

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

K-Number: K152669 · 2016-01-15

ApplicantPms Tip Teknolojileri Sanayi VE Ticaret Limited Std
Decision Date2016-01-15
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is the device name listed in this FDA 510(k) record. The listed applicant is Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152669. 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 PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. The 510(k) number is K152669.

When did PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) receive FDA 510(k) clearance?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152669.

Who is the listed applicant for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

The FDA 510(k) record lists Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

The FDA product code for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) 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.

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