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FDA 510(k)

Caiman 5 Maryland

K-Number: K183180 · 2019-03-12

Decision Date2019-03-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Caiman 5 Maryland is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183180. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caiman 5 Maryland?

Caiman 5 Maryland is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Aesculap, Inc.. The 510(k) number is K183180.

When did Caiman 5 Maryland receive FDA 510(k) clearance?

Caiman 5 Maryland received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183180.

Who is the listed applicant for Caiman 5 Maryland?

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

What is the FDA product code for Caiman 5 Maryland?

The FDA product code for Caiman 5 Maryland is GEI.

Related Clinical Trials

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.

Other records listing Aesculap, Inc. 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: GEI)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.