FDA 510(k)

DISPOSABLE HEMOSTASIS CHIP

K-Number: K121505 · 2012-08-31

ApplicantWilson-Cook Medical Inc./Cook Endoscopy

Decision Date2012-08-31

Product CodePKL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HEMOSTASIS CHIP is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2012-08-31 under 510(k) number K121505. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE HEMOSTASIS CHIP?

DISPOSABLE HEMOSTASIS CHIP is a medical device that received FDA 510(k) clearance on 2012-08-31. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K121505.

When did DISPOSABLE HEMOSTASIS CHIP receive FDA 510(k) clearance?

DISPOSABLE HEMOSTASIS CHIP received FDA 510(k) clearance on 2012-08-31, under 510(k) number K121505.

Who is the listed applicant for DISPOSABLE HEMOSTASIS CHIP?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE HEMOSTASIS CHIP?

The FDA product code for DISPOSABLE HEMOSTASIS CHIP is PKL.

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Related Devices (Code: PKL)

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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.