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FDA 510(k)

ADEL 5000

K-Number: K950889 · 1995-10-16

ApplicantStryker Corp.
Decision Date1995-10-16
Product CodeHDD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ADEL 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1995-10-16 under 510(k) number K950889. The device is classified under product code HDD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADEL 5000?

ADEL 5000 is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Stryker Corp.. The 510(k) number is K950889.

When did ADEL 5000 receive FDA 510(k) clearance?

ADEL 5000 received FDA 510(k) clearance on 1995-10-16, under 510(k) number K950889.

Who is the listed applicant for ADEL 5000?

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

What is the FDA product code for ADEL 5000?

The FDA product code for ADEL 5000 is HDD.

Other records listing Stryker Corp. as applicant

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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Related Devices (Code: HDD)

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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