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FDA 510(k)

WINNER SELF SEAL STERILIZATION POUCH

K-Number: K051242 · 2005-12-13

ApplicantWinner Medical (Usa), Inc.
Decision Date2005-12-13
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WINNER SELF SEAL STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical (Usa), Inc.. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K051242. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINNER SELF SEAL STERILIZATION POUCH?

WINNER SELF SEAL STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Winner Medical (Usa), Inc.. The 510(k) number is K051242.

When did WINNER SELF SEAL STERILIZATION POUCH receive FDA 510(k) clearance?

WINNER SELF SEAL STERILIZATION POUCH received FDA 510(k) clearance on 2005-12-13, under 510(k) number K051242.

Who is the listed applicant for WINNER SELF SEAL STERILIZATION POUCH?

The FDA 510(k) record lists Winner Medical (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WINNER SELF SEAL STERILIZATION POUCH?

The FDA product code for WINNER SELF SEAL STERILIZATION POUCH is KCT.

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Related Devices (Code: KCT)

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.

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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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