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FDA 510(k)

STRYKER QUIKFLAP STERILE PROCEDURE PACK

K-Number: K120352 · 2012-06-11

ApplicantStryker
Decision Date2012-06-11
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER QUIKFLAP STERILE PROCEDURE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2012-06-11 under 510(k) number K120352. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER QUIKFLAP STERILE PROCEDURE PACK?

STRYKER QUIKFLAP STERILE PROCEDURE PACK is a medical device that received FDA 510(k) clearance on 2012-06-11. The listed applicant is Stryker. The 510(k) number is K120352.

When did STRYKER QUIKFLAP STERILE PROCEDURE PACK receive FDA 510(k) clearance?

STRYKER QUIKFLAP STERILE PROCEDURE PACK received FDA 510(k) clearance on 2012-06-11, under 510(k) number K120352.

Who is the listed applicant for STRYKER QUIKFLAP STERILE PROCEDURE PACK?

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

What is the FDA product code for STRYKER QUIKFLAP STERILE PROCEDURE PACK?

The FDA product code for STRYKER QUIKFLAP STERILE PROCEDURE PACK is GWO.

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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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