FDA 510(k)

STRYKER PAINPUMP PCA

K-Number: K003543 · 2001-06-05

Decision Date2001-06-05

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRYKER PAINPUMP PCA is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2001-06-05 under 510(k) number K003543. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER PAINPUMP PCA?

STRYKER PAINPUMP PCA is a medical device that received FDA 510(k) clearance on 2001-06-05. The listed applicant is Stryker Instruments. The 510(k) number is K003543.

When did STRYKER PAINPUMP PCA receive FDA 510(k) clearance?

STRYKER PAINPUMP PCA received FDA 510(k) clearance on 2001-06-05, under 510(k) number K003543.

Who is the listed applicant for STRYKER PAINPUMP PCA?

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

What is the FDA product code for STRYKER PAINPUMP PCA?

The FDA product code for STRYKER PAINPUMP PCA is FRN.

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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.